MLN9708 and Dexamethasone for High-Risk Smoldering Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01660997|
Recruitment Status : Withdrawn
First Posted : August 9, 2012
Last Update Posted : December 16, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: MLN9708 Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MLN9708 and Dexamethasone in High Risk Smoldering Multiple Myeloma: A Clinical and Correlative Pilot Study|
|Study Start Date :||July 30, 2012|
|Actual Primary Completion Date :||March 11, 2014|
|Actual Study Completion Date :||March 11, 2014|
- Response rate [ Time Frame: 3 years ]
- Progression-free survival [ Time Frame: 4 years ]
- Duration of response [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660997
|Principal Investigator:||Carl O Landgren, M.D.||National Cancer Institute (NCI)|