Tests talquetamab in adults with relapsed or refractory multiple myeloma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma that has come back or has stopped responding to treatment. The disease must be measurable by laboratory tests.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Multiple myeloma confirmed by IMWG diagnostic criteria. It must be measurable by laboratory assessment (central laboratory for cohorts A to D, local laboratory for cohort E). The disease has relapsed or is refractory.

Earlier treatment

Part 3, cohorts A and C: no earlier CAR-T or T cell redirection therapy at any time. Cohorts B, D and E: no T cell redirection therapy within 3 months. Side effects of earlier cancer treatment must have settled to Grade 1 or less, except hair loss or nerve problems in the hands and feet.

Main reasons for not taking part

• Earlier CAR-T or T cell redirection therapy (timing depends on the cohort)
• Side effects of earlier cancer treatment above Grade 1, except hair loss or nerve problems in the hands and feet
• Corticosteroids equal to 140 mg or more of prednisone in the 14 days before the first dose (not counting medicine given before treatment)
• Stroke or seizure in the 6 months before signing consent

The registry criteria, word for word

What the trial wants to find out

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

The 5 groups in the trial

• Part 3: Cohort A (Talquetamab)Treatment being tested

  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.

  Treatment: Talquetamab

• Part 3: Cohort B (Talquetamab)Treatment being tested

  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.

  Treatment: Talquetamab

• Part 3: Cohort C (Talquetamab)Treatment being tested

  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.

  Treatment: Talquetamab

• Part 3: Cohort D (Talquetamab)Treatment being tested

  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.

  Treatment: Talquetamab

• Part 3: Cohort E (Talquetamab)Treatment being tested

  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.

  Treatment: Talquetamab