This open-label, multicenter clinical trial using the oral formulation of MLN9708 will have both phase 1 and phase 2 components. Both phases will include patients with newly diagnosed multiple myeloma who have not previously received systemic treatment. The main objective of the phase 1 portion of the study is to determine the safety, tolerability and maximum tolerated dose of oral MLN9708 administered weekly in combination with lenalidomide and low-dose dexamethasone. The main objective of the phase 2 portion of the study is to determine the response rate following treatment of oral MLN9708 administered weekly in combination with lenalidomide and low-dose dexamethasone.
Inclusion Criteria:
Each patient must meet all of the following eligibility criteria to be enrolled in the study:
- Male or female patients 18 years or older
- Previously untreated multiple myeloma diagnosed according to standard criteria requiring systemic treatment
- Patients must have measurable disease
- Nosecretory multiple myeloma based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite?) is evaluated Patients must meet clinical laboratory criteria as specified in study protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Female and male patients MUST adhere to the guidelines of the lenalidomide pregnancy prevention program
- Must be able to take concurrent aspirin 325 mg daily
- Voluntary written consent
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Peripheral neuropathy that is greater or equal to Grade 2
- Female patients who are lactating or pregnant
- Major surgery or radiotherapy within 14 days before the first dose of study drug
- Serious infection requiring systematic antibiotic therapy within 14 days before the first dose of study drug
- Diarrhea greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events
- Central nervous system involvement.
- Evidence of current uncontrolled cardiovascular conditions within the past 6 months
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- Known gastrointestinal condition that could interfere with swallowing or the oral absorption of tolerance of MLN9708
- No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection
Last updated: 03/26/2012
NCT ID: NCT01217957
IRB Number:10-004943
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