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

NCT ID: NCT00622336

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-01
• Study Completion Date: 2013-11-25

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide 25mg (CC-5013)

Oral 25mg daily on Days 1-21 every 28 days

Group Type: EXPERIMENTAL

CC-5013

Intervention Type: DRUG

Oral 25mg daily on Days 1-21 every 28 days.

Lenalidomide

Intervention Type: DRUG

Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Interventions

CC-5013

Oral 25mg daily on Days 1-21 every 28 days.

Intervention Type: DRUG

Lenalidomide

Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Intervention Type: DRUG

Other Intervention Names

Revlimid; lenalidomide; Revlimid; CC-5013

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Knight, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Republican Clinical Hospital #1

Izhevsk, , Russia

Nizhny Novgorod Clinical Hospital n.a.Semashko

Nizhny Novgorod, , Russia

Novosibirsk State Regional Clinical

Novosibirsk, , Russia

Samara Regional Clinical Hospital

Samara, , Russia

Kharkov Postgraduate Medical Academy Kharkov Regional Clinical

Kharkiv, , Ukraine

Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

Kiev, , Ukraine

Odessa Regional Clinical Hospital

Odesa, , Ukraine

Countries

Russia; Ukraine

Other Identifiers

2004-002102-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-5013-MM-012

Identifier Type: -

Identifier Source: org_study_id