Phase 1B Clinical Trial Studying the Safety, Activity, and Effectiveness of Cevostamab in Treating People with Relapsed or Refractory Multiple Myeloma
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What's the purpose of this trial?

The goal of this clinical trial is to learn how well cevostamab works and how safe it is when used by itself or when used in combination with other medicines to treat people with relapsed or refractory multiple myeloma.

Researchers in this clinical trial are looking to enroll approximately 120 people with relapsed or refractory multiple myeloma who have previously been treated for their disease with at least one other medicine.  People participating in this trial will be divided into three different groups. Group A will receive cevostamab as their only treatment (also called cevostamab monotherapy).  Group B will receive cevostamab in addition to two other medicines - pomalidomide and dexamethasone.  And Group C will receive cevostamab in addition to daratumumab and dexamethasone.  Additional information about when and how each group will receive their treatment is provided below.  

In addition to splitting participants into different treatment groups (also known as treatment arms), this clinical trial will take a phased approach to enrollment.  Each treatment arm will first include approximately 6 patients. When these people have completed 1 full cycle of treatment, and if there are no safety concerns, an additional 30 people will be enrolled into the treatment arm. Researchers are taking this approach because this is an early trial of cevostamab, which is an investigational medicine, and it is important that there is a close follow-up to ensure treatment safety.  

 All participants will need to be hospitalized for approximately 48 hours while receiving their first two or three doses of Cevostamab. Specific hospitalization requirements will depend on which group patients participate in. 

This trial is open but patient recruitment is temporarily on hold.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • Participants must have measurable disease as defined by the trial criteria.
  • Participants must have relapsed disease (multiple myeloma that has become active again after effective treatment) or refractory disease (multiple myeloma that has not responded to treatment or has become resistant to it).
  • Participants must have not previously received Cevostamab, or any other agent targeting FcRH5.
  • Participants must not have received a CAR T-Cell therapy in the previous 12 weeks.
  • Participants must not have ever received an allogeneic stem cell transplant, and have not received an autologous stem cell transplant in the previous 100 days. 
  • Participants must not have a history of autoimmune disease.
  • Participants must have adequate liver, kidney, cardiac, pulmonary and bone marrow function as described in the trial criteria. 

Additional Trial Information

Phase 1

Enrollment: 120 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Recruitment on Hold

Colorado

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Not Yet Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Recruitment on Hold

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Recruitment on Hold

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Not Yet Accepting
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