Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma (PEXIUS)
Expanded access is currently available for this treatment.
Verified April 2013 by Celgene Corporation
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01632826
First received: June 29, 2012
Last updated: April 12, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Pomalidomide
U.S. FDA Resources
Further study details as provided by Celgene Corporation:
Intervention Details:
Detailed Description:
-
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
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:
- Histologically documented multiple myeloma
- Age ≥ 18 years
- Must have had at least ≥ 4 prior anti-myeloma therapies
- Must have documented disease progression
- 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 and for at least 28 days after study treatment discontinuation.
- 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:
- Peripheral Neuropathy ≥ Grade 2
- Non-secretory multiple myeloma
- Previous therapy with pomalidomide
- Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment
- Subjects with conditions requiring chronic steroid or immunosuppressive treatment.
- Hypersensitivity to thalidomide, lenalidomide or dexamethasone
- Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
- Pregnant or breastfeeding females
- Unacceptable hematological or biochemical laboratory abnormalities
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632826
Show 25 Study Locations
Contacts
| Contact: Deborah Ingenito | 908-673-9581 | dingenito@celgene.com |
Show 25 Study LocationsSponsors 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 12, 2013 |
| 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 May 23, 2013