Study on Elranatamab for Patients with Relapsed or Refractory Multiple Myeloma
Sponsor: SCRI Development Innovations, LLC
ClinicalTrials ID:NCT07637578
This clinical trial is testing the safety of a new treatment, elranatamab, for patients with multiple myeloma that has returned or not responded to previous treatments. The study will be conducted in an outpatient setting and aims to understand the occurrence of a specific side effect called cytokine release syndrome (CRS) during the first cycle of treatment.
Patient Parameters
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Program Overview
This study is exploring the use of elranatamab, a new treatment for patients with multiple myeloma that has come back or not responded to other treatments. The trial will take place in an outpatient setting and will involve two groups of participants. The main goal is to see how often a side effect called cytokine release syndrome (CRS) occurs during the first cycle of treatment when a preventive dose of tocilizumab is given beforehand.
Description
This Phase II study is testing elranatamab, a new treatment for patients with relapsed or refractory multiple myeloma, meaning the cancer has returned or not responded to previous treatments. Participants must have tried at least one other treatment and been exposed to specific drugs like lenalidomide and an anti-CD38 antibody. The study will start with a small group of six participants to ensure safety, followed by a larger group of 40 participants. All participants will receive a preventive dose of tocilizumab, a medication that helps reduce the risk of cytokine release syndrome (CRS), a potential side effect. Elranatamab is designed to help the immune system target and destroy cancer cells in multiple myeloma. The study aims to evaluate the safety and effectiveness of this treatment approach.
Eligibility Criteria
Inclusion Criteria
- Must provide written informed consent.
- Be at least 18 years old.
- Have a confirmed diagnosis of multiple myeloma.
- Have measurable disease based on specific lab tests.
- Have tried at least one previous treatment and been exposed to lenalidomide and an anti-CD38 antibody.
- Have a performance status score of 0 or 1, indicating good overall health.
- HIV-positive participants must have an undetectable viral load, a CD4+ count over 300, no recent opportunistic infections, and be on stable antiretroviral therapy.
- Have adequate organ function based on specific blood tests.
- Be willing to take preventive medications for certain infections.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
- Men must agree to use condoms and not donate sperm during the study and for 90 days after the last treatment.
Exclusion Criteria
- Have received certain cancer treatments or investigational drugs recently.
- Have had a severe reaction to previous cancer treatments.
- Be taking medications that interfere with the study treatment.
- Have other active cancers or certain blood disorders.
- Have significant heart, neurological, or psychiatric conditions.
- Have active infections like hepatitis B or C.
- Be pregnant, nursing, or planning to become pregnant or father a child during the study and for a specified period after.
- Have any condition that would prevent compliance with the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| Willamette Valley Cancer Institute and Research Center | 97401 | Eugene | Oregon |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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