A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Overview

The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose (RP2D) (Part 3).

SparkCures ID 1106
Trial Phase Phase 2
Enrollment 158 Patients
Treatments
Tags
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT04634552

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Part 3: Measurable disease cohort A and cohort B: multiple myeloma must be measurable by central laboratory assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Part 3 only: Cohort A only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B: T cell redirection therapy within 3 months
  • Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of talquetamab
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

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Norton Cancer Institute St. Matthews Campus

Louisville, KY

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Providence Portland Medical Center

Portland, OR

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Winship Cancer Institute of Emory University

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Alabama
Arkansas
California
Georgia
Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more

Illinois
Kentucky
Norton Cancer Institute St. Matthews Campus

Louisville, KY

Michigan
Missouri
Verified Alvin J. Siteman Cancer Center Washington University Medical Campus

SparkCures Verified Accurate, up-to-date information. Learn more

New York
University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

North Carolina
Ohio
Oregon
Providence Portland Medical Center

Portland, OR

Tennessee
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

There are no resources, links or videos to display for this clinical trial.

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