Study on Elranatamab Alone or with Daratumumab Compared to Daratumumab, Pomalidomide, and Dexamethasone for Treating Relapsed or Refractory Multiple Myeloma
Sponsor: Pfizer
ClinicalTrials ID:NCT05020236
This clinical trial is testing whether a new drug, Elranatamab, alone or combined with Daratumumab, is more effective for treating multiple myeloma that has returned or not responded to previous treatments, compared to a standard treatment combination.
Patient Parameters
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Program Overview
The study aims to find out if Elranatamab, a new type of drug, can help people with multiple myeloma more than the current standard treatment. It will test Elranatamab by itself and with another drug, Daratumumab, against a combination of Daratumumab, Pomalidomide, and Dexamethasone. Participants will have previously been treated with lenalidomide and a proteasome inhibitor. The study has two parts: the first part will check the safety and effects of different doses of Elranatamab with Daratumumab. In the second part, participants will be randomly assigned to receive either Elranatamab alone, Elranatamab with Daratumumab, or the standard treatment. The study will continue until the disease worsens, side effects become too severe, or participants choose to stop.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma.
- Have measurable disease based on specific medical tests.
- Previously treated with lenalidomide and a proteasome inhibitor.
- Able to perform daily activities with some limitations (ECOG score of 2 or less).
- Any side effects from previous treatments have returned to normal or are mild.
- Not pregnant and willing to use birth control.
Exclusion Criteria
- Have smoldering multiple myeloma, plasma cell leukemia, amyloidosis, or POEMS Syndrome.
- Had a stem cell transplant within the last 12 weeks or have active graft versus host disease.
- Have active infections like hepatitis B, hepatitis C, COVID-19, or HIV.
- Have another active cancer within the last 3 years, except for certain skin cancers or carcinoma in situ.
- Previously treated with a BCMA-targeted therapy.
- Received anti-CD38 therapy within the last 6 months.
- Had a live vaccine within 4 weeks before starting the study.
- Participating in another clinical trial or received an investigational product within 30 days before starting this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clovis Community Medical Center | 93611 | Clovis | California |
| Community Cancer Institute | 93611 | Clovis | California |
| University of California San Francisco | 93701 | Fresno | California |
| Community Regional Medical Center | 93721 | Fresno | California |
| UCHealth Poudre Valley Hospital | 80524 | Fort Collins | Colorado |
| UCHealth Harmony | 80528 | Fort Collins | Colorado |
| UCHealth Greeley Hospital | 80634 | Greeley | Colorado |
| UCHealth - Medical Center of the Rockies | 80538 | Loveland | Colorado |
| Sylvester Comprehensive Cancer Center - Aventura | 33180 | Aventura | Florida |
| Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center | 33146 | Coral Gables | Florida |
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