Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05757973
Talquetamab, a bispecific antibody targeting GPRC5D and CD3, is offered in a pre-approval access program for relapsed or refractory multiple myeloma patients who have exhausted all other treatments and are ineligible for clinical trials. Administered subcutaneously, the program monitors safety through adverse event reporting.
Patient Parameters
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Program Overview
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.
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.
Eligibility Criteria
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
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