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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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