MMRC Horizon One Adaptive Platform Trial for Evaluating Treatments in Relapsed or Refractory Multiple Myeloma
Sponsor: Multiple Myeloma Research Consortium
ClinicalTrials ID:NCT06171685
This clinical trial is designed to find the best treatment options for patients with relapsed or refractory multiple myeloma. The trial can adapt over time to include new treatment options as they become available.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is an adaptive platform trial, meaning it can change and include new treatment options as they become available. The goal is to efficiently find the best treatment for patients with relapsed or refractory multiple myeloma. Different treatment options, called investigational arms, will be tested under a main protocol. New arms can be added when they are ready, and each arm will have specific guidelines for when it will stop accepting new patients.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of multiple myeloma that has come back or is not responding to previous treatments.
- Must have tried treatments that include a proteasome inhibitor, an immunomodulating agent, and a CD38-monoclonal antibody.
- Have measurable disease, such as specific levels of M-protein or other markers in blood or urine tests.
- Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function based on specific blood test results.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days after the last treatment.
- Men must agree to use effective birth control during the study and for 90 days after the last treatment.
- Must not have severe heart disease or other conditions that would make participation unsafe.
- Must be willing and able to follow the study requirements.
Exclusion Criteria
- Have a different type of cancer that could interfere with the study.
- Have active infections or other serious medical conditions.
- Have a history of severe allergic reactions to any of the study treatments.
- Have complete spinal cord compression or cancer that has spread to the brain.
- Have received a transplant and require high doses of steroids.
- Have a psychiatric or substance abuse disorder that would interfere with participation.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| Emory Winship Cancer Center | 30322 | Atlanta | Georgia |
| University of Chicago Cancer Center | 60637 | Chicago | Illinois |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute/Harvard Medical School | 02215 | Boston | Massachusetts |
| Barbara Ann Karmanos Cancer Center | 48201 | Detroit | Michigan |
| Mayo Clinic Rochester | 55905 | Rochester | Minnesota |
| Washington University Medicine | 63110 | St. Louis | Missouri |
| Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
| Memorial Sloan Kettering Cancer Center | 10022 | New York | New York |
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