Overview

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

Status:
Approved for marketing
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Details
Lead Sponsor:
Celgene
Celgene Corporation
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Pomalidomide
Thalidomide
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