Status:
COMPLETED
A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 lena...
Detailed Description
The drug being tested in this study is called ixazomib. Ixazomib was being tested to treat people who had newly diagnosed multiple myeloma who had not previously received systemic treatment. This stud...
Eligibility Criteria
Inclusion
- 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
- 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
- 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 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
Exclusion
Key Trial Info
Start Date :
November 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01217957
Start Date
November 22 2010
End Date
February 2 2018
Last Update
March 14 2018
Active Locations (16)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Rocky Mountain Cancer Center Rose
Denver, Colorado, United States, 80218
4
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489