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

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Talquetamab — DRUG
  Talquetamab will be administered by subcutaneous (SC) injection.
• Teclistamab — DRUG
  Teclistamab will be administered by SC injection.

Study Details

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R\[s\]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).

Key Dates

Start date

Dec 15, 2020

Status verified

Jan 2026

Primary completion

Mar 18, 2025

Completion

Oct 27, 2026

Study Design

Enrollment

228 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Dose Escalation
  Participants will receive tec+tal in 28-day cycles following initial step-up doses. Upon sponsor notification, participants will enter the long-term extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.
• Experimental: Part 2: Dose Expansion
  Participants will receive treatment doses (combination of tal+tec regimen) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.
• Experimental: Part 3: Phase 2
  Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.

Primary Outcome Measure

Part 1: Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Approximately 5 years 10 months ]

Locations (13)

Find similar trials in Birmingham, AL

Related Studies

• Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Family Study of Lymphoproliferative Disorders
  Recruiting · Mayo Clinic · Rochester, Minnesota
• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
  Recruiting · Ohio State University Comprehensive Cancer Center · Columbus, Ohio