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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Relapsed or Refractory Multiple Myeloma

Interventions

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Talquetamab

Talquetamab will be administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

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JNJ-64407564

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No