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Talquetamab for Relapsed or Refractory Multiple Myeloma

This study is testing a drug called talquetamab in people with multiple myeloma (a type of blood cancer) that has come back or not responded to previous treatments. Talquetamab will be given as an injection under the skin until your disease gets worse. The main goal is to see how many people respond to the treatment, measured for up to 2 years and 10 months. You may be able to join if you are 18 or older, have a confirmed diagnosis of multiple myeloma, and your disease can be measured by lab tests. The study is currently recruiting about 510 participants.

Study design
This study is testing talquetamab in about 510 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Talquetamab will be given as an injection under the skin until your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
The main outcome will be measured for up to 2 years and 10 months.

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NCT04634552

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~510 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Talquetamab

At a glance

Recruiting sites
14 of 78 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Up to 2 years and 10 months

Conditions

Hematological Malignancies

Explore related trials

Hematologic NeoplasmMultiple Myeloma

Where it's being run

78 sites across 22 states
Japan13
Spain11
China8
France6
South Korea6
Israel5
Poland5
Belgium4

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • 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.