Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

Phase 3

Active, not recruiting

• Conditions: DS Stage I Multiple Myeloma; DS Stage II Multiple Myeloma; DS Stage III Multiple Myeloma; Refractory Multiple Myeloma; Smoldering Multiple Myeloma

• Registration Number: NCT00114101
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-6-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage<br> >= 1) and have stable disease or be responsive to at least 2 months of any induction<br> therapy; patients with smoldering myeloma are not eligible unless the disease has<br> progressed to >= stage 1<br><br> - No more than 12 months of any prior therapy, including CC-5013 and thalidomide<br><br> - Within 12 months of initiation of induction therapy<br><br> - No prior progression after initial therapy; in addition, no more than two regimens<br> will be allowed excluding dexamethasone alone<br><br> - No prior peripheral blood, bone marrow, or solid organ transplant<br><br> - Patients must have peripheral blood stem cell collection of >= 2 x 10^6 cluster of<br> differentiation (CD)34+ cells/kg (patient body weight) and preferably 5 x 10^6<br> cells/kg (patient body weight); stem cells may be collected at any time prior to<br> transplant; peripheral blood stem cell collection may occur before or after<br> registration<br><br> - Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of<br> 0-1<br><br> - Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) > 50%<br> predicted with no symptomatic pulmonary disease<br><br> - Patients must have left ventricular ejection fraction (LVEF) >= 40% by multi gated<br> acquisition scan (MUGA) or echocardiogram<br><br> - Patients must not have uncontrolled diabetes mellitus<br><br> - Patients must not have an active serious infection<br><br> - Patients must not be human immunodeficiency virus (HIV), hepatitis B surface antigen<br> (HBSag), or hepatitis (Hep) C positive<br><br> - Patients must be non-pregnant and non-nursing; women of childbearing potential must<br> have a negative serum or urine pregnancy test with a sensitivity of at least 25<br> mIU/mL 10-14 days prior to registration and repeated within 24 hours prior to the<br> first dose of lenalidomide; in addition, women of childbearing potential taking<br> lenalidomide must have a pregnancy test performed by the doctor weekly during the<br> first 4 weeks of treatment, and then every 4 weeks if menses are regular and every 2<br> weeks if menses are irregular, and then 30 days following the last dose of<br> lenalidomide; women of childbearing potential must either commit to continued<br> abstinence from heterosexual intercourse or begin two acceptable methods of birth<br> control - one highly effective method (intrauterine device [IUD], hormonal, tubal<br> ligation, or partner's vasectomy), and one additional effective method (latex<br> condom, diaphragm, or cervical cap) - at the same time, at least 4 weeks before she<br> begins lenalidomide therapy; women of childbearing potential is defined as a<br> sexually mature woman who has not undergone a hysterectomy or who has had menses at<br> any time in the preceding 24 consecutive months; men must agree not to father a<br> child and must use a latex condom during any sexual contact with women of<br> childbearing potential while taking lenalidomide and for 4 weeks after therapy is<br> stopped, even if they have undergone a successful vasectomy<br><br> - Absolute neutrophil count (ANC) >= 1000/uL<br><br> - Platelets >= 100,000/uL<br><br> - Creatinine clearance* >= 40 cc/min<br><br> - To be calculated by method of Cockcroft-Gault or after 24-hour urine collection<br><br> - Creatinine =< 2 mg/dL<br><br> - Total bilirubin =< 2 mg/dL<br><br> - Aspartate aminotransferase (AST) =< 3 x upper limits of normal<br><br> - Alkaline phosphatase =< 3 x upper limits of normal<br><br> - Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative (if patient of<br> childbearing potential)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Progression

Secondary Outcome Measures

Name	Time	Method
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100