Clinical trial NCT00622336: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma
Official title: Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Revlimid
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AE) During the Treatment Phase
timeFrame: Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.
measure: Number of Participants With Adverse Events (AE) During the Extension Phase
timeFrame: From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.
Secondary outcomes:
measure: Time to Progression
timeFrame: Up to 70 months
measure: Myeloma Response Rate
timeFrame: Up to 70 months
measure: Duration of Response
timeFrame: Up to 70 months
Other outcomes:
Locations:
city: Izhevsk
country: Russian Federation
facility: Republican Clinical Hospital #1
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Clinical Hospital n.a.Semashko
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital
city: Kharkov
country: Ukraine
facility: Kharkov Postgraduate Medical Academy Kharkov Regional Clinical
city: Kiev
country: Ukraine
facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
city: Odessa
country: Ukraine
facility: Odessa Regional Clinical Hospital
Study officials:
affiliation: Celgene Corporation
name: Robert Knight, MD
role: STUDY_DIRECTOR
References: