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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment510 people
  • Recruiting US sites9
  • SponsorJanssen Research & Development, LLC
  • RegistryNCT04634552

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma: a one-minute explainerNCT046345521 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

You cannot join if

  • Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

talquetamab-tgvs. A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen (TAA), with potential antineoplastic activity. Upon administration, talquetamab-tgvs binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells. This results in the cross-linking of T cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against GPRC5D-expressing tumor cells. GPRC5D is overexpressed on certain tumors, such as multiple myeloma, while minimally expressed on normal, healthy cells, and plays a key role in tumor cell proliferation. NCI Drug Dictionary

Treatments listed in the registry

  • Talquetamab (Drug): Talquetamab will be administered SC until disease progression.

The study

Treatment groups

Non Randomized · Parallel · masking: None

Part 3: Cohort A (Talquetamab) (Experimental)

Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.

Part 3: Cohort B (Talquetamab) (Experimental)

Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.

Part 3: Cohort C (Talquetamab) (Experimental)

Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.

Part 3: Cohort D (Talquetamab) (Experimental)

Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.

Part 3: Cohort E (Talquetamab) (Experimental)

Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.

Goals

What the study measures

Main goals

  • Overall Response Rate (ORR) (Up to 2 years and 10 months)

Other goals

  • Duration of Response (DOR)
  • Very Good Partial Response (VGPR) or Better Rate
  • Complete Response (CR) or Better Rate
  • Stringent Complete Response (sCR) Rate
  • Time to Response (TTR)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Minimal Residual Disease (MRD) Negative Rate
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
  • Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
  • Number of Participants with AEs by Severity
  • Number of Participants with Abnormalities in Clinical Laboratory Values
  • Serum Concentration of Talquetamab
  • Number of Participants with Talquetamab Antibodies
  • Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
  • Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
  • Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
  • Overall Response Rate (ORR) in Participants with High-risk Molecular Features

Planned enrollment: 510 (estimated).

Where

Recruiting US sites

  • University of Alabama Birmingham, Birmingham, Alabama
  • University of Arkansas for Medical Sciences, Little Rock, Arkansas
  • Memorial Healthcare System, Hollywood, Florida
  • Emory University Winship Cancer Institute, Atlanta, Georgia
  • Norton Cancer Institute, Louisville, Kentucky
  • University of Michigan Health System, Ann Arbor, Michigan
  • Washington University School Of Medicine, St Louis, Missouri
  • Mount Sinai Medical Center, New York, New York
  • University of Rochester Medical Center, Rochester, New York

5 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Background research

Papers linked by the registry

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 24, 2026. Public record; not medical advice.

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