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

Multiple Myeloma Clinical Trial

— PEXIUS  

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01632826
• Other study ID #: CC-4047-MM-009
• Status: Approved for marketing

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Canada	Celgene Study Site	Calgary	Alberta
Canada	Celgene Study Site	Edmonton	Alberta
Canada	Celgene Study Site	Halifax	Nova Scotia
Canada	Celgene Study Site	Hamilton	Ontario
Canada	Celgene Study Site	London	Ontario
Canada	Celgene Study Site	Montreal	Quebec
Canada	Celgene Study Site	Montreal	Quebec
Canada	Celgene Study Site	Montreal	Quebec
Canada	Celgene Study Site	Ottawa	Ontario
Canada	Celgene Study Site	Quebec City	Quebec
Canada	Celgene Study Site	Saskatoon	Saskatchewan
Canada	Celgene Study Site	St. John's	Newfoundland and Labrador
Canada	Celgene Study Site	Toronto	Ontario
Canada	Celgene Study Site	Vancouver	British Columbia
Canada	Celgene Study Site	Victoria	British Columbia
Canada	Celgene Study Site	Windsor	Ontario
Canada	Celgene Study Site	Winnipeg	Manitoba
United States	Celgene Study Site	Baltimore	Maryland
United States	Celgene Study Site	Dallas	Texas
United States	Celgene Study Site	Denver	Colorado
United States	Celgene Study Site	Duarte	California
United States	Celgene Study Site	Greenbrae	California
United States	Celgene Study Site	Greenville	South Carolina
United States	Celgene Study Site	Hackensack	New Jersey
United States	Celgene Study Site	Houston	Texas
United States	Celgene Study Site	Hyannis	Massachusetts
United States	Celgene Study Site	Indianapolis	Indiana
United States	Celgene Study Site	Iowa City	Iowa
United States	Celgene Study Site	Los Angeles	California
United States	Celgene Study Site	Marietta	Georgia
United States	Celgene Study Site	Milwaukee	Wisconsin
United States	Celgene Study Site	Morgantown	West Virginia
United States	Celgene Study Site	New York	New York
United States	Celgene Study Site	New York	New York
United States	Celgene Study Site	Omaha	Nebraska
United States	Celgene Study Site	Peoria	Illinois
United States	Celgene Study Site	Philadelphia	Pennsylvania
United States	Celgene Study Site	Saint Louis	Missouri
United States	Celgene Study Site	Salt Lake City	Utah
United States	Celgene Study Site	Sellersville	Pennsylvania
United States	Celgene Study Site	Sioux Falls	South Dakota
United States	Celgene Study Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation