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NCT00114101 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Time to Progression

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outcome · POSTED

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

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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)
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Procedure: Autologous Hematopoietic Stem Cell Transplantation
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Lenalidomide
    4. Drug: Melphalan
    5. Procedure: Peripheral Blood Stem Cell Transplantation
    label
    Arm I (melphalan, autologous PBSCT, lenalidomide)
    type
    EXPERIMENTAL
  2. description
    Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Procedure: Autologous Hematopoietic Stem Cell Transplantation
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Melphalan
    4. Procedure: Peripheral Blood Stem Cell Transplantation
    5. Other: Placebo Administration
    label
    Arm II (melphalan, autologous PBSCT, placebo)
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (melphalan, autologous PBSCT, lenalidomide)
    2. Arm II (melphalan, autologous PBSCT, placebo)
    description
    Undergo autologous PBSCT
    name
    Autologous Hematopoietic Stem Cell Transplantation
    other Names
    1. AHSCT
    2. Autologous
    3. Autologous Hematopoietic Cell Transplantation
    4. Autologous Stem Cell Transplant
    5. Autologous Stem Cell Transplantation
    6. Stem Cell Transplantation, Autologous
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm I (melphalan, autologous PBSCT, lenalidomide)
    2. Arm II (melphalan, autologous PBSCT, placebo)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  3. arm Group Labels
    1. Arm I (melphalan, autologous PBSCT, lenalidomide)
    description
    Given PO
    name
    Lenalidomide
    other Names
    1. CC 5013
    2. CC-5013
    3. CC5013
    4. CDC 501
    5. Revlimid
    type
    DRUG
  4. arm Group Labels
    1. Arm I (melphalan, autologous PBSCT, lenalidomide)
    2. Arm II (melphalan, autologous PBSCT, placebo)
    description
    Given IV
    name
    Melphalan
    other Names
    1. Alanine Nitrogen Mustard
    2. CB-3025
    3. L-PAM
    4. L-Phenylalanine Mustard
    5. L-Sarcolysin
    6. L-Sarcolysin Phenylalanine mustard
    7. L-Sarcolysine
    8. Melphalan for Injection-Hepatic Delivery System
    9. Melphalanum
    10. Phenylalanine Mustard
    11. Phenylalanine Nitrogen Mustard
    12. Sarcoclorin
    type
    DRUG
  5. arm Group Labels
    1. Arm I (melphalan, autologous PBSCT, lenalidomide)
    2. Arm II (melphalan, autologous PBSCT, placebo)
    description
    Undergo autologous PBSCT
    name
    Peripheral Blood Stem Cell Transplantation
    other Names
    1. PBPC transplantation
    2. PBSCT
    3. Peripheral Blood
    4. Peripheral Blood Progenitor Cell Transplantation
    5. PERIPHERAL BLOOD STEM CELL TRANSPLANT
    6. Peripheral Stem Cell Support
    7. Peripheral Stem Cell Transplant
    8. Peripheral Stem Cell Transplantation
    type
    PROCEDURE
  6. arm Group Labels
    1. Arm II (melphalan, autologous PBSCT, placebo)
    description
    Given PO
    name
    Placebo Administration
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
460
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    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.
    measure
    Overall Survival
    time Frame
    Duration of study (up to 10 years)
primary Outcomes
  1. description
    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: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia
    measure
    Time to Progression
    time Frame
    Duration of study (up to 10years)
secondary Outcomes
  1. description
    Response was defined according to International Myeloma Working Group criteria (2006) * Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Partial Response: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels * Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour * Progressive Disease: Defined in primary outcome measure * Stable Disease: Not meeting any of the criteria above
    measure
    Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
    time Frame
    Day 100
Full study description
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.
Source references
references
  1. citation
    Holstein SA, Jung SH, Richardson PG, Hofmeister CC, Hurd DD, Hassoun H, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, van Besien K, Gentile TG, Isola L, Maziarz RT, Bashey A, Landau H, Martin T, Qazilbash MH, Rodriguez C, McClune B, Schlossman RL, Smith SE, Hars V, Owzar K, Jiang C, Boyd M, Schultz C, Wilson M, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Linker C, Anderson KC, McCarthy PL. Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol. 2017 Sep;4(9):e431-e442. doi: 10.1016/S2352-3026(17)30140-0. Epub 2017 Aug 17.
    pmid
    28826616
    type
    DERIVED
  2. citation
    McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, Van Besien K, Gentile T, Isola L, Maziarz RT, Gabriel DA, Bashey A, Landau H, Martin T, Qazilbash MH, Levitan D, McClune B, Schlossman R, Hars V, Postiglione J, Jiang C, Bennett E, Barry S, Bressler L, Kelly M, Seiler M, Rosenbaum C, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Anderson KC, Linker C. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1770-81. doi: 10.1056/NEJMoa1114083.
    pmid
    22571201
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice