Study on Elranatamab for Treating Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: University of California, San Diego
ClinicalTrials ID:NCT06711705
This clinical trial is testing the effectiveness of the drug elranatamab in patients with multiple myeloma that has returned or not responded to previous treatments. Participants should have tried 1 to 3 different treatment combinations before joining this study.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate how well the drug elranatamab works in patients with multiple myeloma that has come back or is difficult to treat. Patients who have already tried 1 to 3 different treatment combinations can participate. If patients show no signs of the disease for more than 12 months, they may enter a period of observation without treatment.
Description
This Phase II study is focused on patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy. The study will assess the effectiveness of elranatamab in these patients. If a patient achieves a sustained response with no detectable disease for over a year, they may enter a treatment-free observation period. The study aims to provide insights into the potential benefits of elranatamab for patients with challenging cases of multiple myeloma.
Eligibility Criteria
Inclusion Criteria
- Must provide signed consent to participate and follow study procedures.
- Must have a prior diagnosis of relapsed or refractory multiple myeloma and have received 1 to 3 previous treatments, including specific types of therapies.
- Must be 18 years or older.
- Must have measurable disease based on specific medical tests.
- Must have a performance status score of 0, 1, or 2, indicating good overall health.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must live within 30 minutes of the treatment site and have a reliable caregiver.
- Must not have severe reactions to similar treatments in the past.
- Must have resolved any side effects from previous treatments.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
Exclusion Criteria
- Cannot have certain types of multiple myeloma or related conditions.
- Cannot have active cancer other than multiple myeloma that required treatment in the past 3 years.
- Cannot have known involvement of the central nervous system by multiple myeloma.
- Cannot have active, uncontrolled autoimmune disorders or infections.
- Cannot have received radiation therapy or systemic treatment too close to the start of the study.
- Cannot have had a stem cell transplant or be on immunosuppressive therapy recently.
- Cannot have uncontrolled medical conditions or significant heart disease.
- Cannot have severe nerve damage or a history of certain neurological conditions.
- Cannot have had major surgery or psychiatric conditions that may affect participation.
- Cannot be pregnant or breastfeeding.
- Cannot have known allergies to the study drug or its components.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego | 92037 | La Jolla | California |
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