Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma (PEXIUS)

November 7, 2019 updated by: Celgene

A Multicenter, Single-Arm, Open-Label Treatment Use Protocol for Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

Several clinical studies indicate that pomalidomide has activity in relapsed and refractory multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2 mg/day and/or 4 mg/day.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Celgene Study Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Celgene Study Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Celgene Study Site
      • Victoria, British Columbia, Canada, V8R6V5
        • Celgene Study Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Celgene Study Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B3V6
        • Celgene Study Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Celgene Study Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Celgene Study Site
      • London, Ontario, Canada, N6A 4G5
        • Celgene Study Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Celgene Study Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Celgene Study Site
      • Windsor, Ontario, Canada, N8W1L9
        • Celgene Study Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Celgene Study Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Celgene Study Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Celgene Study Site
      • Quebec City, Quebec, Canada, G1R 2J6
        • Celgene Study Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Celgene Study Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • Celgene Study Site
      • Greenbrae, California, United States, 94904
        • Celgene Study Site
      • Los Angeles, California, United States, 90048
        • Celgene Study Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Celgene Study Site
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Celgene Study Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Celgene Study Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Celgene Study Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Celgene Study Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Celgene Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Celgene Study Site
    • Massachusetts
      • Hyannis, Massachusetts, United States, 02601
        • Celgene Study Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Celgene Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Celgene Study Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Celgene Study Site
    • New York
      • New York, New York, United States, 10016
        • Celgene Study Site
      • New York, New York, United States, 10029
        • Celgene Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Celgene Study Site
      • Sellersville, Pennsylvania, United States, 18960
        • Celgene Study Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Celgene Study Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Celgene Study Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Celgene Study Site
      • Houston, Texas, United States, 77030
        • Celgene Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Celgene Study Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Celgene Study Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Celgene Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
  2. Age ≥ 18 years
  3. Must have had at least ≥ 2 prior anti-myeloma therapies
  4. Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
  5. Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
  6. Must have documented disease progression during or after the last antimyeloma regimen
  7. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting drug, while participating in the study and for at least 28 days after study treatment discontinuation.
  8. Males must agree to use a latex condom during sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment.

Exclusion Criteria:

  1. Peripheral Neuropathy ≥ Grade 2
  2. Non-secretory multiple myeloma
  3. Previous therapy with pomalidomide
  4. Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment
  5. Subjects with conditions requiring chronic steroid or immunosuppressive treatment.
  6. Hypersensitivity to thalidomide, lenalidomide or dexamethasone
  7. Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
  8. Pregnant or breastfeeding females
  9. Unacceptable hematological or biochemical laboratory abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Lars Sternas, MD, PhD, Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-4047-MM-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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