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

Last updated: November 7, 2019
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Red Blood Cell Disorders

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT00622336
CC-5013-MM-012
2004-002102-30
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andhigh-dose dexamethasone or high-dose dexamethasone alone due to: documented disease progression OR inability to tolerate the lowest dosing regimen allowedon 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 ofcontraception

Exclusion

Exclusion Criteria:

  • Prior development of a ≥ grade 2 allergic reaction/hypersensitivity or priordevelopment of a grade ≥ 3 rash or desquamation while taking thalidomide NationalCancer Institute Common toxicity Criteria (NCI CTC)

  • Use of any standard/experimental anti-myeloma therapy within 28 days of randomizationor use of any experimental non-drug therapy within 56 days of initiation of drugtreatment

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

  • 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 thecervix 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 onstudy 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 marrownucleated cells re plasma cells; Platelet count <30,000/mm^3 (30 X 10^9/L) for thosewith <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

Study Design

Total Participants: 330
Study Start date:
April 01, 2003
Estimated Completion Date:
November 25, 2013

Connect with a study center

  • Republican Clinical Hospital #1

    Izhevsk, 426039
    Russian Federation

    Site Not Available

  • Nizhny Novgorod Clinical Hospital n.a.Semashko

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Novosibirsk State Regional Clinical

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Samara Regional Clinical Hospital

    Samara, 443095
    Russian Federation

    Site Not Available

  • Kharkov Postgraduate Medical Academy Kharkov Regional Clinical

    Kharkov, 61070
    Ukraine

    Site Not Available

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

    Kiev, 04060
    Ukraine

    Site Not Available

  • Odessa Regional Clinical Hospital

    Odessa, 65025
    Ukraine

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.