A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Trial end date: 2018-02-02
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Glycine; Ixazomib; Lenalidomide; Proteasome Inhibitors; Thalidomide

Criteria

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