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

Phase 2

Recruiting

• Conditions: Hematological Malignancies

• Registration Number: JPRN-jRCT2031210621
• Lead Sponsor: Fujikawa Ei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

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: multiple myeloma must be measurable by central 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

Exclusion Criteria

- Part 3 only: Cohort A and cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B: T cell redirection therapy within 3 months
- Participants who received or plan to receive any live, attenuated vaccine within 4 weeks prior to the first dose, during treatment, or within 4 weeks of the last dose of talquetamab. Non-live or non-replicating vaccines approved or authorized for emergency use (example, COVID-19) by local health authorities are allowed
- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR):Up to 2 years and 10 months:ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.