Status:
ACTIVE_NOT_RECRUITING
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
DS Stage I Multiple Myeloma
DS Stage II Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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. Givin...
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). SE...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage \>= 1) and have stable disease or be responsive to at least 2 months of any induction therapy; patients with smoldering myeloma are not eligible unless the disease has progressed to \>= stage 1
- No more than 12 months of any prior therapy, including CC-5013 and thalidomide
- Within 12 months of initiation of induction therapy
- No prior progression after initial therapy; in addition, no more than two regimens will be allowed excluding dexamethasone alone
- No prior peripheral blood, bone marrow, or solid organ transplant
- Patients must have peripheral blood stem cell collection of \>= 2 x 10\^6 cluster of differentiation (CD)34+ cells/kg (patient body weight) and preferably 5 x 10\^6 cells/kg (patient body weight); stem cells may be collected at any time prior to transplant; peripheral blood stem cell collection may occur before or after registration
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) \> 50% predicted with no symptomatic pulmonary disease
- Patients must have left ventricular ejection fraction (LVEF) \>= 40% by multi gated acquisition scan (MUGA) or echocardiogram
- Patients must not have uncontrolled diabetes mellitus
- Patients must not have an active serious infection
- Patients must not be human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSag), or hepatitis (Hep) C positive
- Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL 10-14 days prior to registration and repeated within 24 hours prior to the first dose of lenalidomide; in addition, women of childbearing potential taking lenalidomide must have a pregnancy test performed by the doctor weekly during the first 4 weeks of treatment, and then every 4 weeks if menses are regular and every 2 weeks if menses are irregular, and then 30 days following the last dose of lenalidomide; women of childbearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (intrauterine device \[IUD\], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (latex condom, diaphragm, or cervical cap) - at the same time, at least 4 weeks before she begins lenalidomide therapy; "women of childbearing" potential is defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months; men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy
- Absolute neutrophil count (ANC) \>= 1000/uL
- Platelets \>= 100,000/uL
- Creatinine clearance\* \>= 40 cc/min
- To be calculated by method of Cockcroft-Gault or after 24-hour urine collection
- Creatinine =\< 2 mg/dL
- Total bilirubin =\< 2 mg/dL
- Aspartate aminotransferase (AST) =\< 3 x upper limits of normal
- Alkaline phosphatase =\< 3 x upper limits of normal
- Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative (if patient of childbearing potential)
Exclusion
Key Trial Info
Start Date :
December 15 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2026
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00114101
Start Date
December 15 2004
End Date
February 22 2026
Last Update
November 24 2025
Active Locations (140)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103