Overview

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

Status:
Completed
Trial end date:
2013-11-25
Target enrollment:
0
Participant gender:
All
Summary
The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celgene
Celgene Corporation
Treatments:
Lenalidomide
Thalidomide
Criteria
Inclusion Criteria:

- Understand and voluntarily sign an informed consent form.

- Age ≥ 18 years at time of signing the informed consent form.

- Able to adhere to the study visit schedule and other protocol requirements

- Participants with multiple myeloma and were enrolled in either THAL-MM-003,
CC-5013-MM-009, or CC-5013-MM-010 and discontinued study therapy with thalidomide and
high-dose dexamethasone or high-dose dexamethasone alone due to:

documented disease progression OR inability to tolerate the lowest dosing regimen allowed
on previous protocol without a grade 3 or 4 toxicity.

- Eastern Cooperative Oncology Group (ECOG) performance status score 0,1,2

- Recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (NCI CTC)

- Females of child-bearing potential (FCBP) must agree to using two methods of
contraception

Exclusion Criteria:

- Prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior
development of a grade ≥ 3 rash or desquamation while taking thalidomide National
Cancer Institute Common toxicity Criteria (NCI CTC)

- Use of any standard/experimental anti-myeloma therapy within 28 days of randomization
or use of any experimental non-drug therapy within 56 days of initiation of drug
treatment

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
will prevent the participant from signing the informed consent form or that will place
the participant at an unacceptable risk for toxicity if he/she participates in the
study.

- Pregnant or lactating females.

- Prior therapy with CC-5013; prior history of malignancies, other than multiple myeloma
(except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the
cervix or breast), unless subject has been free of disease for ≥ 5 years

- More than 4 months has elapsed since the last dose of study drug was administered on
study Tal MM-003, CC-5013-MM-009, CC-5013-MM-010

- Absolute neutrophil count (ANC) <1,000cells/mm^3 (1.0 X 10^9/L)

- Platelet count <75,000/mm^3 (30 X 10^9/L) for those with <50% if the bone marrow
nucleated cells re plasma cells; Platelet count <30,000/mm^3 (30 X 10^9/L) for those
with <50% if the bone marrow nucleated cells re plasma cells

- Serum creatinine >2.5mg/dL; serum SGOT/AST or SGPT/ALT x upper limits of normal (ULN)

- Serum total bilirubin >2.0mg/d/L