A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Completed · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.
Key facts
- Study ID
- NCT01217957
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 65
- Starts
- 2010-11-22
- Expected to finish
- 2018-02-02
- Last updated by the study team
- 2018-03-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Nonsecretory 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
You may not qualify if…
- 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 systemic 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 or tolerance of ixazomib
- No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection
Where it is running
- Mayo Clinic Arizona — Scottsdale, Arizona, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Rocky Mountain Cancer Center Rose — Denver, Colorado, United States
- Cancer Center of Central Connecticut — Southington, Connecticut, United States
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- Mt Sinai Medical Center — Miami Beach, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Harry and Jeannette Weinberg Cancer Center at Franklin Square Hospital — Baltimore, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University — St Louis, Missouri, United States
- New York Presbyterian Hospital - Weill-Cornell — New York, New York, United States
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States
- W VA University Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States
- The Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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