CClinicalTrials.gg
Approved for marketingNCT01632826PEXIUSUpdated Nov 12, 2019

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

An expanded access record providing Pomalidomide in Multiple Myeloma, sponsored by Celgene. Approved for marketing at 42 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.

Sponsored by Celgene · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Relapsed
  • refractory multiple myeloma
  • pomalidomide
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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
05

Access details

Study type
Expanded access

Available treatment

  • DrugPomalidomide

    4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation

06

Where to request access

42 sites
  • Celgene Study Site
    Duarte, California 91010, United States
  • Celgene Study Site
    Greenbrae, California 94904, United States
  • Celgene Study Site
    Los Angeles, California 90048, United States
  • Celgene Study Site
    Denver, Colorado 80218, United States
  • Celgene Study Site
    West Palm Beach, Florida 33401, United States
  • Celgene Study Site
    Marietta, Georgia 30060, United States
  • Celgene Study Site
    Peoria, Illinois 61615, United States
  • Celgene Study Site
    Indianapolis, Indiana 46202, United States
  • Celgene Study Site
    Iowa City, Iowa 52242, United States
  • Celgene Study Site
    Baltimore, Maryland 21215, United States
  • Celgene Study Site
    Hyannis, Massachusetts 02601, United States
  • Celgene Study Site
    Saint Louis, Missouri 63110, United States
  • Celgene Study Site
    Omaha, Nebraska 68198, United States
  • Celgene Study Site
    Hackensack, New Jersey 07601, United States
  • Celgene Study Site
    New York, New York 10016, United States
  • Celgene Study Site
    New York, New York 10029, United States
  • Celgene Study Site
    Philadelphia, Pennsylvania 19107, United States
  • Celgene Study Site
    Sellersville, Pennsylvania 18960, United States
  • Celgene Study Site
    Greenville, South Carolina 29615, United States
  • Celgene Study Site
    Sioux Falls, South Dakota 57105, United States
  • Celgene Study Site
    Dallas, Texas 75390, United States
  • Celgene Study Site
    Houston, Texas 77030, United States
  • Celgene Study Site
    Salt Lake City, Utah 84106, United States
  • Celgene Study Site
    Morgantown, West Virginia 26506, United States
  • Celgene Study Site
    Milwaukee, Wisconsin 53226, United States
  • Celgene Study Site
    Calgary, Alberta T2N 4N2, Canada
  • Celgene Study Site
    Edmonton, Alberta T6G 1Z2, Canada
  • Celgene Study Site
    Vancouver, British Columbia V5Z1M9, Canada
  • Celgene Study Site
    Victoria, British Columbia V8R6V5, Canada
  • Celgene Study Site
    Winnipeg, Manitoba R3E 0V9, Canada
  • Celgene Study Site
    St. John's, Newfoundland and Labrador A1B3V6, Canada
  • Celgene Study Site
    Halifax, Nova Scotia B3H 1V7, Canada
  • Celgene Study Site
    Hamilton, Ontario L8V 5C2, Canada
  • Celgene Study Site
    London, Ontario N6A 4G5, Canada
  • Celgene Study Site
    Ottawa, Ontario K1H 8L6, Canada
  • Celgene Study Site
    Toronto, Ontario M5G 2M9, Canada
  • Celgene Study Site
    Windsor, Ontario N8W1L9, Canada
  • Celgene Study Site
    Montreal, Quebec H1T 2M4, Canada
  • Celgene Study Site
    Montreal, Quebec H3A 1A1, Canada
  • Celgene Study Site
    Montreal, Quebec H3T 1E2, Canada
  • Celgene Study Site
    Quebec City, Quebec G1R 2J6, Canada
  • Celgene Study Site
    Saskatoon, Saskatchewan S7N 4H4, Canada
07

References and documents

Publications

  • Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2. PubMed 30068263 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01632826
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Jul 3, 2012
Last update
Nov 12, 2019

Study contacts

Lars Sternas, MD, PhD
study director · Celgene Corporation
View the source record on ClinicalTrials.gov ↗

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