Trial started· ClinicalTrials.gov
Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
Talquetamab History and Updates
121 events · 2017 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
9
FDA Approvals
0
Label Revisions
112
Trial Milestones
0
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 Talquetamab since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (3)
2026
- Primary completionTalquetamab Phase 3 Trial for Multiple Myeloma Reaches Primary Completion· Apr 23, 2026
- Primary completionTalquetamab Phase 3 Trial for Relapsed/Refractory Myeloma Reaches Primary…· Apr 1, 2026
2023
- FDA approvalTalvey (talquetamab) Gains Initial FDA Approval as New Molecular Entity· Aug 9, 2023
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Trial started· ClinicalTrials.gov
MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Primary completion· ClinicalTrials.gov
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
Primary completion· ClinicalTrials.gov
Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
Trial started· ClinicalTrials.gov
BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
Primary completion· ClinicalTrials.gov
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants
Primary completion· ClinicalTrials.gov
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Re
Primary completion· ClinicalTrials.gov
Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Comb
Primary completion· ClinicalTrials.gov
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy
Primary completion· ClinicalTrials.gov
Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone
Primary completion· ClinicalTrials.gov
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
Primary completion· ClinicalTrials.gov
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the
Primary completion· ClinicalTrials.gov
The Norwegian Immunotherapy in Multiple Myeloma Study
Primary completion· ClinicalTrials.gov
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Primary completion· ClinicalTrials.gov
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Primary completion· ClinicalTrials.gov
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
Primary completion· ClinicalTrials.gov
MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
Primary completion· ClinicalTrials.gov
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol
Primary completion· ClinicalTrials.gov
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol
Primary completion· ClinicalTrials.gov
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalid
Primary completion· ClinicalTrials.gov
Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
Primary completion· ClinicalTrials.gov
BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
Past events
2026
Trial registered· ClinicalTrials.gov
Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Primary completion· ClinicalTrials.gov
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi
Primary completion· ClinicalTrials.gov
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
Primary completion· ClinicalTrials.gov
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi
Primary completion· ClinicalTrials.gov
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
Trial started· ClinicalTrials.gov
Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
Trial registered· ClinicalTrials.gov
BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Primary completion· ClinicalTrials.gov
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Mye
2025
Trial started· ClinicalTrials.gov
Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Trial started· ClinicalTrials.gov
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Re
Trial started· ClinicalTrials.gov
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: Labeling.
Trial started· ClinicalTrials.gov
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
Trial started· ClinicalTrials.gov
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Trial registered· ClinicalTrials.gov
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Trial registered· ClinicalTrials.gov
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Re
Trial started· ClinicalTrials.gov
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma
Trial started· ClinicalTrials.gov
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Trial registered· ClinicalTrials.gov
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Primary completion· ClinicalTrials.gov
A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Par
Primary completion· ClinicalTrials.gov
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Primary completion· ClinicalTrials.gov
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
The Norwegian Immunotherapy in Multiple Myeloma Study
Trial registered· ClinicalTrials.gov
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
Trial started· ClinicalTrials.gov
The Norwegian Immunotherapy in Multiple Myeloma Study
2024
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Trial started· ClinicalTrials.gov
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol
Trial registered· ClinicalTrials.gov
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
Trial started· ClinicalTrials.gov
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
Trial started· ClinicalTrials.gov
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Fol
Trial registered· ClinicalTrials.gov
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Trial registered· ClinicalTrials.gov
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Trial registered· ClinicalTrials.gov
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Trial started· ClinicalTrials.gov
Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone
Trial started· ClinicalTrials.gov
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Trial registered· ClinicalTrials.gov
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Trial registered· ClinicalTrials.gov
Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone
Trial registered· ClinicalTrials.gov
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Trial started· ClinicalTrials.gov
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi
Trial registered· ClinicalTrials.gov
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomi
2023
Trial started· ClinicalTrials.gov
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: REMS.
Trial registered· ClinicalTrials.gov
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the
Trial started· ClinicalTrials.gov
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy
Trial started· ClinicalTrials.gov
A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy
Trial started· ClinicalTrials.gov
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
FDA approval· FDA
Sponsor: JANSSEN BIOTECH. Class: Type 1 - New Molecular Entity.
Trial registered· ClinicalTrials.gov
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Trial registered· ClinicalTrials.gov
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
Trial registered· ClinicalTrials.gov
Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
2022
Trial started· ClinicalTrials.gov
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
Primary completion· ClinicalTrials.gov
A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalid
Trial started· ClinicalTrials.gov
A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Comb
Trial registered· ClinicalTrials.gov
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalid
Trial registered· ClinicalTrials.gov
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Comb
Primary completion· ClinicalTrials.gov
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
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 registered· ClinicalTrials.gov
A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Par
2021
Trial started· ClinicalTrials.gov
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
2020
Trial started· ClinicalTrials.gov
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial registered· ClinicalTrials.gov
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants
2019
Trial registered· ClinicalTrials.gov
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants
2018
Trial started· ClinicalTrials.gov
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Mye
Trial registered· ClinicalTrials.gov
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Mye
Trial registered· ClinicalTrials.gov
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
2017
Trial started· ClinicalTrials.gov
Dose Escalation Study of Talquetamab 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.