MLN9708 and Dexamethasone for High-Risk Smoldering Multiple Myeloma
- Smoldering multiple myeloma (SMM) is a condition that can lead to multiple myeloma, a type of blood cancer. In many high-risk cases, SMM can develop into multiple myeloma in less than 2 years. The current standard of care for SMM is follow-up without treatment until multiple myeloma develops. However, some drugs are being studied to see if they can slow down or prevent the disease from progressing. One such drug is MLN9708. It has shown some results against multiple myeloma. Researchers want to combine MLN9708 with dexamethasone to see how it works against high-risk SMM.
- To see if MLN9708 with dexamethasone is a safe and effective treatment for high-risk smoldering multiple myeloma.
- Individuals at least 18 years of age who have high-risk smoldering multiple myeloma.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and a bone marrow biopsy may also be performed.
- Participants will take MLN9708 and dexamethasone on a regular schedule for 28 days. They will take each drug four times at regular intervals during each cycle of treatment.
- Treatment will be monitored with frequent blood tests and imaging studies.
- Participants will have 12 cycles of treatment. After four cycles, patients will be recommended to have their own stem cells collected and stored. This will allow the potential application of a highdose melpahalan/autologous stem cell transplant in the event there is a need in the future (not part of this study).
- After 12 cycles, participants will keep taking MLN9708 as long as the disease does not progress and the side effects are not too severe.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||MLN9708 and Dexamethasone in High Risk Smoldering Multiple Myeloma: A Clinical and Correlative Pilot Study|
- Response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Contact: Marcia Mulquin, R.N.||(301) email@example.com|
|Contact: Carl O Landgren, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Not yet recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Carl O Landgren, M.D.||National Cancer Institute (NCI)|