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

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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
  Purpose

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


Condition Intervention
Multiple Myeloma
Drug: Pomalidomide

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632826

  Show 42 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Lars Sternas, MD, PhD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01632826     History of Changes
Other Study ID Numbers: CC-4047-MM-009
Study First Received: June 29, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Celgene Corporation:
Relapsed
refractory multiple myeloma
pomalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 22, 2014