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Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Available
CT.gov ID
NCT05757973
Collaborator
(none)

Study Details

Study Description

Brief Summary

The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that produce antibodies] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Talquetamab (JNJ-64407564) is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G-Protein Coupled Receptor (5DGPRC5D) and cluster of differentiation 3 (CD3). Redirecting T-cells to a tumor surface antigen using bispecific antibody approaches may be an effective means to harness the immune system to destroy cancer cells expressing GPRC5D and create meaningful and long-lasting clinical responses. Talquetamab is supplied as single-dose Investigational Product (IP) vials for subcutaneous administration. Safety assessments will include adverse events, serious adverse events, adverse drug reactions, and special situations which will be reported during the duration of the pre-approval access program.

Study Design

Study Type:
Expanded Access
Official Title:
Pre-Approval Access Named Patient Program for Talquetamab (JNJ-64407564) for Treating Physician Use in Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Participant diagnosed with relapsed or refractory multiple, myeloma

    • Participant exhausted all commercially approved and clinically appropriate treatment options, and is ineligible for a clinical trial

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05757973
    Other Study ID Numbers:
    • CR109170
    • 64407564MMY4003
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Mar 7, 2023