Phase
Condition
Multiple Myeloma
Red Blood Cell Disorders
Lymphoproliferative Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Republican Clinical Hospital #1
Izhevsk, 426039
Russian FederationSite Not Available
Nizhny Novgorod Clinical Hospital n.a.Semashko
Nizhny Novgorod, 603126
Russian FederationSite Not Available
Novosibirsk State Regional Clinical
Novosibirsk, 630087
Russian FederationSite Not Available
Samara Regional Clinical Hospital
Samara, 443095
Russian FederationSite Not Available
Kharkov Postgraduate Medical Academy Kharkov Regional Clinical
Kharkov, 61070
UkraineSite Not Available
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
Kiev, 04060
UkraineSite Not Available
Odessa Regional Clinical Hospital
Odessa, 65025
UkraineSite Not Available
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