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

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210621

Enrollment

320

Registered

2022-02-19

Start date

2022-07-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancies

Interventions

Talquetamab:Talquetamab will be administered 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 until

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
-Duration of Response (DOR):Up to 2 years and 10 months:DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first. -Very Good Partial Response (VGPR) or Better Rate:Up to 2 years and 10 months:VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. -Complete Response (CR) or Better Rate:Up to 2 years and 10 months:CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria. -Stringent Complete Response (sCR) Rate:Up to 2 years and 10 months:sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria. -Time to Response (TTR):Up to 2 years and 10 months:TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. -Progression-Free Survival (PFS):Up to 2 years and 10 months:PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. -Overall Survival (OS):Up to 2 years and 10 months:OS is defined as the time from the date of first dose of study drug to the date of the participants death. -Minimal Residual Disease (MRD) Negative Rate:Up to 2 years and 10 months:MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data. -Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability:Up to 2 years and 10 months:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. -Number of Participants	—

Measure

Time frame

-Duration of Response (DOR):Up to 2 years and 10 months:DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first. -Very Good Partial Response (VGPR) or Better Rate:Up to 2 years and 10 months:VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. -Complete Response (CR) or Better Rate:Up to 2 years and 10 months:CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria. -Stringent Complete Response (sCR) Rate:Up to 2 years and 10 months:sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria. -Time to Response (TTR):Up to 2 years and 10 months:TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. -Progression-Free Survival (PFS):Up to 2 years and 10 months:PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. -Overall Survival (OS):Up to 2 years and 10 months:OS is defined as the time from the date of first dose of study drug to the date of the participants death. -Minimal Residual Disease (MRD) Negative Rate:Up to 2 years and 10 months:MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data. -Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability:Up to 2 years and 10 months:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. -Number of Participants

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Countries

Belgium, China, France, Germany, Israel, Japan, Korea, Netherlands, Poland, Spain, UnitedStates Of America

Contacts

Public ContactMedical Information Center

Janssen Pharmaceutical K.K.

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com+81-120-183-275

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026