Overview

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 (Freeliteā„¢) 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