NCT05757973

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

First QC Date

December 14, 2022

Last Update Submit

December 8, 2025

Conditions

Interventions

Talquetamab will be administered subcutaneously.

Also known as: JNJ-64407564

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

RecurrenceMultiple Myeloma

Interventions

talquetamab

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

March 7, 2023

Last Updated

December 9, 2025

Record last verified: 2025-12