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NCT05757973 Clinical Trial

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

Relapsed or Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT05757973
Other study ID # CR109170
Secondary ID 64407564MMY4003
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date August 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Talquetamab
Talquetamab will be administered subcutaneously.

Locations
Country Name City State
Brazil DUMMY Dummy
Germany DUMMY Dummy
Italy DUMMY Dummy
Netherlands DUMMY Dummy
Romania DUMMY Dummy
Switzerland DUMMY Dummy
United Kingdom DUMMY Dummy

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Brazil,  Germany,  Italy,  Netherlands,  Romania,  Switzerland,  United Kingdom, 

See also
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Completed NCT03464916 - Study to Evaluate the Safety and Efficacy of Anti-CD38 CAR-T in Relapsed or Refractory Multiple Myeloma Patients Phase 1
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Not yet recruiting NCT06298266 - To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma Early Phase 1
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Terminated NCT02075021 - Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma Phase 1/Phase 2
Completed NCT00478777 - A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma Phase 3