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

Information source: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: IXAZOMIB + Lenalidomide + Dexamethasone (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Millennium Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Millennium Pharmaceuticals, Inc.

Summary

This open-label, multicenter clinical trial using the oral formulation of IXAZOMIB 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 IXAZOMIB 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 IXAZOMIB administered weekly in combination with lenalidomide and low-dose dexamethasone.

Clinical Details

Official title: An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Objective response rate following treatment with the combination of oral IXAZOMIB, lenalidomide and low-dose dexamethasone

Recommended phase 2 dose of IXAZOMIB given in combination with lenalidomide and low-dose dexamethasone

Maximum tolerated dose (MTD) of IXAZOMIB administered weekly in combination with lenalidomide and low-dose dexamethasone

Secondary outcome:

Pharmacokinetics (PK) in plasma of IXAZOMIB in combination with lenalidomide and low-dose dexamethasone

Pharmacodynamic effect of IXAZOMIB in combination with lenalidomide and low-dose dexamethasone

Time to progression

Overall survival and other long term outcomes

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- 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 (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 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 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

Locations and Contacts

Mayo Clinic- Scottsdale, Scottsdale, Arizona 85259, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Rocky Mountain Cancer Center, Denver, Colorado 80218, United States

Cancer Center of Central Connecticut, Southington, Connecticut 06489, United States

Mayo Clinic, Jacksonville, Florida 32224, United States

Mount Sinai Medical Center, Miami, Florida 33140, United States

Emory University, Atlanta, Georgia 30322, United States

The Harry and Jeanette Weinberg Cancer Institute, Baltimore, Maryland 21237, United States

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Karmanos Cancer Institute, Detroit, Michigan 48021, United States

Mayo Clinic- Rochester, Rochester, Minnesota 55095, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Weill-Cornell Medical College, New York City, New York 10021, United States

Tennessee Oncology, Nashville, Tennessee 37203, United States

Mary Babb Rudolph Cancer Center, Morgantown, West Virginia 26506, United States

Medical College Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: November 2010
Last updated: May 23, 2014

Page last updated: August 23, 2015

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