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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05757973
Expanded Access Status : Approved for marketing
First Posted : March 7, 2023
Last Update Posted : September 5, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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
Relapsed or Refractory Multiple Myeloma Drug: Talquetamab

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
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Pre-Approval Access Named Patient Program for Talquetamab (JNJ-64407564) for Treating Physician Use in Relapsed or Refractory Multiple Myeloma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Interventions
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Intervention Details:
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other Name: JNJ-64407564
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757973


Locations
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Brazil
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Germany
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Dummy, Germany, 99999
Italy
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Dummy, Italy, 99999
Netherlands
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Dummy, Netherlands, 99999
Romania
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Dummy, Romania, 99999
Switzerland
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Dummy, Switzerland, 99999
United Kingdom
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Dummy, United Kingdom, 99999
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05757973    
Other Study ID Numbers: CR109170
64407564MMY4003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases