Teclistamab History and Updates

179 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

168

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Teclistamab since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (5)

2026

FDA approval (supplemental)Teclistamab Supplemental Application Approved for Efficacy by FDA· Mar 5, 2026

2025

Primary completionTeclistamab Phase 3 Trial in Relapsed/Refractory Myeloma Reaches Primary…· Oct 13, 2025

2024

FDA approval (supplemental)Tecvayli (teclistamab) Receives FDA Supplemental Efficacy Approval· Nov 22, 2024
FDA approval (supplemental)Tecvayli (teclistamab) receives supplemental FDA approval for efficacy· Feb 20, 2024

2022

FDA approvalTecvayli (Teclistamab) Receives Initial FDA Approval as New Molecular Entity· Oct 25, 2022

Upcoming & expected milestones

Trial startedJun 26, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07463807

Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomid

Trial startedJun 30, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07581704

Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma

Trial startedJun 30, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07649525

Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level

Trial startedJul 1, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07029776

MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma

Trial startedJul 1, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07605416

Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial

Trial startedAug 26, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT06948084

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07463807

Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomid

Primary completionSep 7, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06758375

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Primary completionSep 16, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06465316

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

Trial startedOct 30, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07631208

Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated Wi

Primary completionNov 3, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT07030517

A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma

Primary completionNov 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06505369

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06465316

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06935162

Teclistamab in Previously Treated AL Amyloidosis

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07079423

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07631208

Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated Wi

Primary completionFeb 28, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT07332507

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

Primary completionFeb 28, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06425991

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Primary completionMar 31, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04068597

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Trial startedMar 31, 2027· ClinicalTrials.gov

Phase 4 trial started: NCT07474961

BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.

Primary completionApr 7, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT04108195

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants

Primary completionApr 7, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT04722146

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Primary completionAug 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05972135

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Primary completionSep 30, 2027· ClinicalTrials.gov

Primary completion: NCT06477783

Study on the Clinical Efficacy of Teclistamab

Primary completionFeb 28, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06948084

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide

Primary completionApr 26, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06353022

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone

Primary completionApr 30, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05243797

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Dia

Primary completionJul 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07638683

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple M

Primary completionAug 8, 2028· ClinicalTrials.gov

Phase 1 primary completion: NCT07105059

A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

Primary completionSep 15, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT05695508

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Primary completionSep 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06649695

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Primary completionDec 8, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05083169

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone

Primary completionDec 12, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refract

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06100237

Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the

Primary completionJan 31, 2029· ClinicalTrials.gov

Primary completion: NCT06855121

The Norwegian Immunotherapy in Multiple Myeloma Study

Primary completionApr 29, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07518186

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Primary completionApr 30, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07107529

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Primary completionMay 1, 2029· ClinicalTrials.gov

Phase 1 primary completion: NCT07581704

Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma

Primary completionJun 1, 2029· ClinicalTrials.gov

Phase 1 primary completion: NCT07581704

Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma

Primary completionJul 31, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06171685

MMRC Horizon One: RRMM (MMRC-099)

Primary completionAug 31, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06993675

Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

Primary completionNov 1, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06880601

Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

Primary completionApr 1, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07029776

MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma

Primary completionJul 31, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT05469893

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Primary completionJul 31, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT06577025

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol

Primary completionSep 2, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT06577025

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol

Primary completionApr 30, 2031· ClinicalTrials.gov

Phase 3 primary completion: NCT05552222

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalid

Primary completionOct 31, 2031· ClinicalTrials.gov

Phase 2 primary completion: NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis

Primary completionNov 6, 2032· ClinicalTrials.gov

Phase 2 primary completion: NCT07605416

Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial

Primary completionMay 31, 2033· ClinicalTrials.gov

Phase 3 primary completion: NCT07649525

Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level

Past events

2026

Trial registeredJun 16, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07649525

Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level

Primary completionJun 15, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06251076

Plan Development for Giving Teclistamab in the Outpatient Setting

Trial registeredJun 10, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07638683

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple M

Trial startedJun 8, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07518186

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredJun 5, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07631208

Study of the Efficacy and Safety of a Bispecific Antibody, Teclistamab in Severe Rapidly Progressive Interstitial Lung Disease Associated Wi

Trial startedMay 29, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07332507

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

Trial registeredMay 26, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07605416

Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial

Trial registeredMay 12, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07581704

Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma

FDA approval (supplemental)May 6, 2026· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — REMS (BLA 761291 S-17)

Sponsor: JANSSEN BIOTECH. Class: REMS.

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05572229

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Trial startedApr 29, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT06948084

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide

Primary completionApr 23, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06208150

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi

Primary completionApr 22, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04696809

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Primary completionApr 13, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04696809

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredApr 8, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07518186

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Primary completionApr 1, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06208150

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi

Trial registeredMar 16, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07474961

BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.

Trial registeredMar 11, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07463807

Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomid

FDA approval (supplemental)Mar 5, 2026· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — Efficacy (BLA 761291 S-18)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Primary completionMar 3, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05849610

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Trial startedFeb 4, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refract

Trial registeredJan 12, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07332507

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

2025

Primary completionDec 31, 2025· ClinicalTrials.gov

NA primary completion: NCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Trial startedDec 12, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07107529

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Trial registeredDec 2, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07258511

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refract

Trial startedNov 7, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis

Trial startedNov 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06880601

Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

Primary completionOct 13, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT04722146

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Primary completionOct 13, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05572515

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Partici

FDA approval (supplemental)Oct 2, 2025· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — REMS (BLA 761291 S-15)

Sponsor: JANSSEN BIOTECH. Class: REMS.

Primary completionSep 25, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT03145181

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Trial startedAug 21, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06993675

Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

FDA approval (supplemental)Aug 19, 2025· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — Labeling (BLA 761291 S-13)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial startedAug 8, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT07105059

A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

Trial registeredAug 8, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis

Trial registeredAug 6, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07107529

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Trial registeredAug 5, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07105059

A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

Trial registeredJul 23, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07079423

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Trial startedJul 2, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06649695

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Trial startedJun 28, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07079423

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Trial registeredJun 22, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07030517

A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma

Trial registeredJun 19, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07029776

MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma

Trial registeredMay 29, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06993675

Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

Trial startedMay 22, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT07030517

A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma

Primary completionMay 22, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT05338775

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Par

Trial startedMay 21, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06935162

Teclistamab in Previously Treated AL Amyloidosis

Trial registeredApr 29, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06948084

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide

Trial registeredApr 20, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06935162

Teclistamab in Previously Treated AL Amyloidosis

Primary completionApr 1, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06352866

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Primary completionMar 31, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05849610

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Trial startedMar 29, 2025· ClinicalTrials.gov

NA trial started: NCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Primary completionMar 18, 2025· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04586426

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredMar 17, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06880601

Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

Trial registeredMar 3, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06855121

The Norwegian Immunotherapy in Multiple Myeloma Study

Trial startedMar 3, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06758375

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Primary completionFeb 14, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06588660

ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

Trial startedJan 15, 2025· ClinicalTrials.gov

Trial started: NCT06855121

The Norwegian Immunotherapy in Multiple Myeloma Study

Trial registeredJan 3, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06758375

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Trial startedJan 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06352866

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

2024

Trial startedDec 18, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06588660

ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

Trial startedDec 6, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06465316

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

FDA approval (supplemental)Dec 2, 2024· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — REMS (BLA 761291 S-11)

Sponsor: JANSSEN BIOTECH. Class: REMS.

Trial startedDec 1, 2024· ClinicalTrials.gov

Trial started: NCT06477783

Study on the Clinical Efficacy of Teclistamab

FDA approval (supplemental)Nov 22, 2024· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — Efficacy (BLA 761291 S-9)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial registeredNov 21, 2024· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Trial startedNov 19, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06251076

Plan Development for Giving Teclistamab in the Outpatient Setting

Trial startedNov 17, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06171685

MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM

Trial registeredOct 21, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06649695

A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Trial registeredSep 19, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06588660

ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

Trial registeredAug 29, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06577025

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol

Trial startedAug 20, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06577025

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol

Trial registeredJul 17, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06505369

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

FDA approval (supplemental)Jul 2, 2024· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — REMS (BLA 761291 S-7)

Sponsor: JANSSEN BIOTECH. Class: REMS.

Trial registeredJun 27, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06477783

Study on the Clinical Efficacy of Teclistamab

Trial startedJun 26, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06353022

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone

Trial startedJun 19, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06505369

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Trial registeredJun 18, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06465316

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

Trial startedJun 7, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06425991

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

FDA approval (supplemental)May 28, 2024· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — Labeling (BLA 761291 S-8)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial registeredMay 23, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06425991

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredApr 8, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06352866

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Trial registeredApr 8, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06353022

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone

FDA approval (supplemental)Feb 20, 2024· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — Efficacy (BLA 761291 S-3)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial registeredFeb 9, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06251076

Plan Development for Giving Teclistamab in the Outpatient Setting

Trial startedJan 22, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06208150

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi

Trial registeredJan 17, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06208150

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi

2023

Trial startedDec 21, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05572229

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Trial registeredDec 15, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06171685

MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM

Trial startedDec 4, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT06100237

Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the

FDA approval (supplemental)Nov 16, 2023· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — REMS (BLA 761291 S-5)

Sponsor: JANSSEN BIOTECH. Class: REMS.

Trial registeredOct 25, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06100237

Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the

Trial startedOct 23, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05972135

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Trial startedSep 21, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05849610

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

FDA approval (supplemental)Aug 9, 2023· FDA

FDA approved supplemental application for Tecvayli (teclistamab-cqyv) — REMS (BLA 761291 S-4)

Sponsor: JANSSEN BIOTECH. Class: REMS.

Trial registeredAug 2, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05972135

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Trial registeredMay 9, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05849610

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Trial startedMar 29, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05572515

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Partici

Trial registeredJan 25, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05695508

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

2022

Trial startedDec 1, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05695508

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Trial startedOct 25, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05552222

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalid

FDA approvalOct 25, 2022· FDA

FDA approved Tecvayli (teclistamab-cqyv) (BLA 761291)

Sponsor: JANSSEN BIOTECH. Class: Type 1 - New Molecular Entity.

Trial registeredOct 7, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05572229

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Trial registeredOct 7, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05572515

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Partici

Trial registeredSep 23, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05552222

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalid

Trial startedSep 8, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05243797

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Dia

Trial startedAug 10, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05469893

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Trial registeredJul 22, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05469893

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Trial registeredJul 19, 2022· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05463939

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Trial startedMay 25, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05338775

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Par

Trial registeredApr 21, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05338775

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Par

Trial registeredFeb 17, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05243797

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Dia

2021

Trial registeredDec 17, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05161598

Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

Primary completionNov 9, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT04557098

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredOct 19, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05083169

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone

Trial startedOct 14, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05083169

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone

Trial startedMar 12, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04722146

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Trial startedFeb 22, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04696809

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredJan 25, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04722146

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Trial registeredJan 6, 2021· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04696809

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

2020

Trial startedDec 15, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04586426

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredOct 14, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04586426

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredSep 21, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04557098

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial startedSep 17, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04557098

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trial startedFeb 21, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04108195

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants

2019

Trial registeredSep 30, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04108195

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants

Trial registeredAug 28, 2019· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04068597

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Trial startedAug 9, 2019· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04068597

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

2017

Trial startedMay 16, 2017· ClinicalTrials.gov

Phase 1 trial started: NCT03145181

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Trial registeredMay 9, 2017· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03145181

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.