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.
SparkCures ID | 1175 |
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Trial Phase | Phase 1 |
Enrollment | 126 Patients |
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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:
Exclusion Criteria:
Please visit the ClinicalTrials.gov page for historical site information.
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