Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
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ClinicalTrials.gov Identifier: NCT00114101 |
Recruitment Status :
Active, not recruiting
First Posted : June 14, 2005
Results First Posted : July 1, 2013
Last Update Posted : March 7, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | June 13, 2005 | |||
First Posted Date ICMJE | June 14, 2005 | |||
Results First Submitted Date ICMJE | March 28, 2013 | |||
Results First Posted Date ICMJE | July 1, 2013 | |||
Last Update Posted Date | March 7, 2024 | |||
Actual Study Start Date ICMJE | December 15, 2004 | |||
Actual Primary Completion Date | December 31, 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Time to Progression [ Time Frame: Duration of study (up to 10years) ] Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.
Progression was defined per the International Myeloma Working Group definition as one more of the following:
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100 [ Time Frame: Day 100 ] Response was defined according to International Myeloma Working Group criteria (2006)
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures |
Overall Survival [ Time Frame: Duration of study (up to 10 years) ] Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
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Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant | |||
Official Title ICMJE | A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma | |||
Brief Summary | This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma. | |||
Detailed Description | PRIMARY OBJECTIVE: I. To determine the efficacy of CC-5013 (lenalidomide) in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant (ASCT). SECONDARY OBJECTIVES: I. To determine if CC-5013 will increase the complete response (CR) rate in patients with multiple myeloma following ASCT. II. To compare the progression-free survival (PFS) and overall survival (OS) in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo. III. To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT. OUTLINE: PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION: Mobilization of autologous PBSC will be performed according to institutional guidelines. AUTOLOGOUS PBSC TRANSPLANTATION (PBSCT): Patients receive melphalan intravenously (IV) over 30-60 minutes on day -2 or -1 or over 2 days on days -3 and -2 or -2 and -1. Patients undergo autologous PBSCT on day 0. Patients are then randomized to 1 of 2 maintenance treatment arms. (Note: As of 12/17/09, no more patients will be randomized between lenalidomide and placebo. Patients who have not been randomized as of 12/17/09 will be assigned to lenalidomide.) ARM I: Beginning between day 100-110, patients receive lenalidomide orally (PO) once daily. ARM II: Beginning between day 100-110, patients receive placebo (PO) once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
460 | |||
Original Enrollment ICMJE | Not Provided | |||
Estimated Study Completion Date ICMJE | February 22, 2025 | |||
Actual Primary Completion Date | December 31, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00114101 | |||
Other Study ID Numbers ICMJE | NCI-2009-00439 NCI-2009-00439 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CALGB 100104/ECOG 100104 CDR0000434845 CALGB-100104 ( Other Identifier: Alliance for Clinical Trials in Oncology ) CALGB-100104 ( Other Identifier: CTEP ) U10CA180821 ( U.S. NIH Grant/Contract ) U10CA031946 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | National Cancer Institute (NCI) | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Original Study Sponsor ICMJE | Cancer and Leukemia Group B | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | February 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |