Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma (PEXIUS)
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Information provided by (Responsible Party):
First received: June 29, 2012
Last updated: April 4, 2014
Last verified: April 2014
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
What is Expanded Access?
||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
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
- Age ≥ 18 years
- Must have had at least ≥ 2 prior anti-myeloma therapies
- Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
- Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
- Must have documented disease progression during or after the last antimyeloma regimen
- 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.
- 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.
- 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
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
||Lars Sternas, MD, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 29, 2012
||April 4, 2014
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by Celgene Corporation:
refractory multiple myeloma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents