Clinical trial NCT01632826: Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
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
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Multiple Myeloma
Keywords: Relapsed
refractory multiple myeloma
pomalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-07-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief 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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Celgene Study Site
state: California
city: Greenbrae
country: United States
facility: Celgene Study Site
state: California
city: Los Angeles
country: United States
facility: Celgene Study Site
state: California
city: Denver
country: United States
facility: Celgene Study Site
state: Colorado
city: West Palm Beach
country: United States
facility: Celgene Study Site
state: Florida
city: Marietta
country: United States
facility: Celgene Study Site
state: Georgia
city: Peoria
country: United States
facility: Celgene Study Site
state: Illinois
city: Indianapolis
country: United States
facility: Celgene Study Site
state: Indiana
city: Iowa City
country: United States
facility: Celgene Study Site
state: Iowa
city: Baltimore
country: United States
facility: Celgene Study Site
state: Maryland
city: Hyannis
country: United States
facility: Celgene Study Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Celgene Study Site
state: Missouri
city: Omaha
country: United States
facility: Celgene Study Site
state: Nebraska
city: Hackensack
country: United States
facility: Celgene Study Site
state: New Jersey
city: New York
country: United States
facility: Celgene Study Site
state: New York
city: New York
country: United States
facility: Celgene Study Site
state: New York
city: Philadelphia
country: United States
facility: Celgene Study Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Celgene Study Site
state: Pennsylvania
city: Greenville
country: United States
facility: Celgene Study Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Celgene Study Site
state: South Dakota
city: Dallas
country: United States
facility: Celgene Study Site
state: Texas
city: Houston
country: United States
facility: Celgene Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Celgene Study Site
state: Utah
city: Morgantown
country: United States
facility: Celgene Study Site
state: West Virginia
city: Milwaukee
country: United States
facility: Celgene Study Site
state: Wisconsin
city: Calgary
country: Canada
facility: Celgene Study Site
state: Alberta
city: Edmonton
country: Canada
facility: Celgene Study Site
state: Alberta
city: Vancouver
country: Canada
facility: Celgene Study Site
state: British Columbia
city: Victoria
country: Canada
facility: Celgene Study Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Celgene Study Site
state: Manitoba
city: St. John's
country: Canada
facility: Celgene Study Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Celgene Study Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Celgene Study Site
state: Ontario
city: London
country: Canada
facility: Celgene Study Site
state: Ontario
city: Ottawa
country: Canada
facility: Celgene Study Site
state: Ontario
city: Toronto
country: Canada
facility: Celgene Study Site
state: Ontario
city: Windsor
country: Canada
facility: Celgene Study Site
state: Ontario
city: Montreal
country: Canada
facility: Celgene Study Site
state: Quebec
city: Montreal
country: Canada
facility: Celgene Study Site
state: Quebec
city: Montreal
country: Canada
facility: Celgene Study Site
state: Quebec
city: Quebec City
country: Canada
facility: Celgene Study Site
state: Quebec
city: Saskatoon
country: Canada
facility: Celgene Study Site
state: Saskatchewan
Study officials:
affiliation: Celgene Corporation
name: Lars Sternas, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.