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

  • STATUS
    Recruiting
  • End date
    Nov 29, 2024
  • participants needed
    201
  • sponsor
    Janssen Research & Development, LLC
Updated on 16 September 2021
multiple myeloma
measurable disease

Summary

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

Description

Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). This study consists 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment [EOT (30 days (+ 7 days)] visit); and a post-treatment follow-up phase (until the end of study unless the participant has died, is lost to follow up or has withdrawn consent). Total duration of study is up to 2 years (after the last participant receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and questionnaire will be assessed at specified time points during this study. Participants safety and study conduct will be monitored throughout the study. The corresponding study (NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of the study.

Details
Condition Hematologic Malignancy, Blood disorder, Blood Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies
Treatment Talquetamab
Clinical Study IdentifierNCT04634552
SponsorJanssen Research & Development, LLC
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

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, and 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
Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of talquetamab
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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