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Trial Title:
Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT05757973
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Expanded Access
Overall status:
Approved for marketing
Intervention:
Intervention type:
Drug
Intervention name:
Talquetamab
Description:
Talquetamab will be administered subcutaneously.
Other name:
JNJ-64407564
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
Brazil
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
Germany
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
Italy
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
Netherlands
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
Romania
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
Switzerland
Facility:
Name:
DUMMY
Address:
City:
Dummy
Zip:
99999
Country:
United Kingdom
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05757973
