Study on New Treatments and Transplant for High-Risk Smoldering Multiple Myeloma
Sponsor: International Myeloma Foundation
ClinicalTrials ID:NCT03289299
This clinical trial is testing a combination of four drugs—carfilzomib, lenalidomide, daratumumab, and dexamethasone—to see if they can effectively treat high-risk smoldering multiple myeloma, a condition that can lead to multiple myeloma. The treatment is divided into three phases over a total of 24 cycles, each lasting 28 days.
Patient Parameters
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Program Overview
This study is exploring whether a combination of four drugs can help treat high-risk smoldering multiple myeloma, a condition that can progress to multiple myeloma. The treatment involves three phases: induction, consolidation, and maintenance, each lasting several cycles. The goal is to see if early intervention with these drugs can lead to better outcomes, potentially preventing the disease from progressing. The drugs used in this study have shown promise in treating multiple myeloma and are generally well-tolerated, allowing patients to continue treatment over a long period.
Description
This clinical trial is investigating a new approach to treating high-risk smoldering multiple myeloma, a condition that can develop into multiple myeloma. The study uses a combination of four drugs: carfilzomib, lenalidomide, daratumumab, and dexamethasone. These drugs have been effective in treating multiple myeloma and are being tested together to see if they can prevent the progression of smoldering myeloma.
The treatment is divided into three phases:
- Induction Phase: 6 cycles of treatment
- Consolidation Phase: 6 cycles of treatment
- Maintenance Phase: 12 cycles of treatment
Each cycle lasts 28 days. The study aims to see if this combination can lead to deep responses, meaning a significant reduction in cancer cells, and potentially cure or control the disease long-term. Participants will be monitored for their response to the treatment and any side effects.
Eligibility Criteria
Inclusion Criteria
- Aged between 18 and 80 years.
- Diagnosed with high-risk smoldering multiple myeloma that has not been treated.
- Meet specific criteria based on blood tests and bone marrow analysis.
- Have good kidney, liver, and heart function as shown by specific medical tests.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Men must agree to use effective birth control and not donate sperm during and for 90 days after treatment.
- Willing to provide informed consent and comply with study requirements, including follow-up visits and providing samples for research.
- Able to take aspirin or other blood thinners as needed.
Exclusion Criteria
- Have a different type of blood disorder or active multiple myeloma.
- Have been treated for another cancer within the last 2 years, except for certain skin or cervical cancers.
- Pregnant or breastfeeding women.
- Have uncontrolled infections or serious heart or lung conditions.
- Have severe nerve damage or have had major surgery recently.
- Have uncontrolled cardiovascular conditions or recent heart issues.
- Have active infections like hepatitis B or C, or HIV.
- Have allergies to the study drugs or their components.
- Unable to comply with study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Chicago Medical Center | 60637 | Chicago | Illinois |
| Indiana University Simon Cancer Center | 46202 | Indianapolis | Indiana |
| University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| University of Maryland Medical Center | 21201 | Baltimore | Maryland |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Weill Cornell Medicine | 10022 | New York | New York |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| Swedish Cancer Institute | 98104 | Seattle | Washington |
| Medical College of Wisconsin | 53226 | Milwaukee | Wisconsin |
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