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Safety and Efficacy of Pomali...

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Last Updated: 2023-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-07

Study Completion Date

2022-05-13

Brief Summary

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The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pomalidomide, Bortezomib and Low Dose Dexamethasone

4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\> 75 years old\] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.

Bortezomib

Intervention Type DRUG

Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.

Dexamethasone

Intervention Type DRUG

Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\>75 years old\] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

Bortezomib and Low Dose Dexamethasone

1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day \[≤ 75 years old\]or 10 mg/day \[\> 75 years old\] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

Group Type ACTIVE_COMPARATOR

Bortezomib

Intervention Type DRUG

Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.

Dexamethasone

Intervention Type DRUG

Interventions

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Pomalidomide

Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.

Intervention Type DRUG

Bortezomib

Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Other Intervention Names

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Oral Pomalidomide CC-4047 Velcade

Eligibility Criteria

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Inclusion Criteria

* Must be ≥ 18 years at the time of signing informed consent.
* Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
* Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
* Must have documented disease progression during or after their last anti-myeloma therapy.
* All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Exclusion Criteria

* Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m\^2 dose twice weekly dosing schedule.
* Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
* Non-secretory multiple myeloma.
* Subjects with severe renal impairment requiring dialysis.
* Previous therapy with pomalidomide.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers-Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Amine Bensmaine, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

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Southern Cancer Center

Mobile, Alabama, United States

Site Status

Arizona Oncology

Tucson, Arizona, United States

Site Status

Local Institution - 132

Bangor, Maine, United States

Site Status

University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

University of California San Francisco Fresno Campus

Fresno, California, United States

Site Status

Marin Oncology Associates

Greenbrae, California, United States

Site Status

St. Agnes - Medical Center

Baltimore, Maryland, United States

Site Status

Moore UCSD Cancer Center

La Jolla, California, United States

Site Status

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Cancer Center of Central Connecticut

Southington, Connecticut, United States

Site Status

Local Institution - 153

Southington, Connecticut, United States

Site Status

George Washington Medical Center

Washington D.C., District of Columbia, United States

Site Status

Lynn Cancer Institute

Boca Raton, Florida, United States

Site Status

University Cancer Institute

Boynton Beach, Florida, United States

Site Status

Broward Oncology Associates PA

Fort Lauderdale, Florida, United States

Site Status

Broward Oncology Assoc.

Fort Lauderdale, Florida, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Alves Domenech Oncology and Hematology Clinic

Hollywood, Florida, United States

Site Status

Palm Beach Cancer Institute, LLC

West Palm Beach, Florida, United States

Site Status

Local Institution - 135

Marietta, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

Marietta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Western Kentucky Hematology and Oncology Group, PSC

Paducah, Kentucky, United States

Site Status

Tulane University Medical Center

New Orleans, Louisiana, United States

Site Status

Cancer Care of Maine

Bangor, Maine, United States

Site Status

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Local Institution - 125

Bethesda, Maryland, United States

Site Status