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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01632826
First received: June 29, 2012
Last updated: April 4, 2014
Last verified: April 2014

June 29, 2012
April 4, 2014
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Complete list of historical versions of study NCT01632826 on ClinicalTrials.gov Archive Site
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Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
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

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.

Expanded Access
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Multiple Myeloma
Drug: Pomalidomide
4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation
Other Name: Pomalidomide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01632826
CC-4047-MM-009
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Celgene Corporation
Celgene Corporation
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Study Director: Lars Sternas, MD, PhD Celgene Corporation
Celgene Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP