Study on the Effectiveness and Safety of Cevostamab in Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: Hoffmann-La Roche
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT05535244
This clinical trial is testing a new drug called cevostamab to see if it is safe and effective for patients with multiple myeloma that has returned or is not responding to treatment. The drug is given through an IV infusion.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well cevostamab works and how safe it is for patients with multiple myeloma that has come back or is not responding to other treatments. The drug is administered through an IV infusion, and researchers will also study how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma based on standard criteria.
- Show signs of disease progression after the last treatment, as determined by the study doctor.
- Have previously received certain treatments targeting BCMA and are not responding to three main types of myeloma drugs.
- Be in good general health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 12 weeks.
- Agree to undergo specific tests and procedures, including bone marrow samples.
- Have recovered from side effects of previous cancer treatments to a mild level.
- Women of childbearing potential must agree to use effective birth control during the study and for at least 5 months after the last dose of cevostamab.
- Men must agree to use condoms and avoid donating sperm during the study and for at least 2 months after the last dose of certain medications.
Exclusion Criteria
- Unable to stay in the hospital as required by the study.
- Pregnant or breastfeeding, or planning to become pregnant during the study or shortly after.
- Have previously been treated with cevostamab or similar drugs.
- Have received certain other cancer treatments recently.
- Have a history of severe allergic reactions to similar treatments.
- Have other serious health conditions, such as autoimmune diseases or certain infections.
- Have had another type of cancer within the last 2 years, except for certain low-risk cancers.
- Have significant heart or lung disease.
- Have active infections or have recently been treated for infections.
- Have a history of drug or alcohol abuse within the last year.
- Have any medical condition that the study doctor believes would make participation unsafe or affect the study results.
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