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NCT01731886 · REGISTRY CONDITION SEARCH

Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

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

Phase
PHASE4
Status at capture
COMPLETED
Registry last update
2020-02-05

The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.

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

Complete Response Rate

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outcome · POSTED

Overall Survival Rate (OS)

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outcome · POSTED

Overall Survival Rate (OS)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Progression Free Survival (PFS)

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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: * Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated. * Bone marrow plasmacytosis with \> or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma. * Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or \> 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis. * Age \> or = 18 years. * Life expectancy of greater than 12 months. * Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%). * Adequate organ and marrow function as defined below: * Hgb \> or = 9 g/dL * Absolute Neutrophil Count \> or = 1,500/ ml * Platelets \> or = 50,000/mm3 * Total Bilirubin \< or = 1.5 mg/dL * Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) \< or = 2.5 X upper limit of normal (ULN) * Creatinine \< 2.0 mg/dL * Creatinine Clearance \> or = 50 ml/min * Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. * Ability to understand and the willingness to sign a written informed consent document. * Subjects with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months. * Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or alternative prophylaxis with either low molecular weight heparin or warfarin as recommended. * Eligible for transplant with an age up to and including 75 years. * Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated separately. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per millilitre (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or 2 acceptable methods of birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom. Exclusion Criteria: * Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline. * Receiving any other investigational agents or therapy within 28 days of baseline. * Brain metastases. * Subjects who are pregnant or breast feeding. * History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3). * If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment: * Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices). * Must not have thrombocytopenia requiring transfusion. * Must have a platelet count \> 50,000. * Must have stable INR between 2-3. * Smoldering myeloma or monoclonal gammopathy of undetermined significance. * Active, uncontrolled infection. * Active, uncontrolled seizure disorder (seizures in the last 6 months). * Concurrent use of other anti-cancer agents or treatments. * Positive for HIV or infectious hepatitis, type B or C. * Hypersensitivity to thalidomide. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
    intervention Names
    1. Procedure: Autologous peripheral blood stem cell transplant
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    4. Procedure: Stem cell collection
    5. Drug: Melphalan
    6. Drug: G-CSF
    7. Drug: Cyclophosphamide
    8. Drug: Mesna
    label
    Arm A
    type
    ACTIVE_COMPARATOR
  2. description
    Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
    intervention Names
    1. Drug: Lenalidomide
    2. Drug: Dexamethasone
    3. Procedure: Stem cell collection
    4. Drug: Cyclophosphamide
    5. Drug: Mesna
    label
    Arm B
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm A
    description
    Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
    name
    Autologous peripheral blood stem cell transplant
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm A
    2. Arm B
    description
    Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
    name
    Lenalidomide
    other Names
    1. CC-5013
    2. Revlimid
    type
    DRUG
  3. arm Group Labels
    1. Arm A
    2. Arm B
    description
    Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
    name
    Dexamethasone
    other Names
    1. Decadron
    2. Hexadrol
    3. Dexameth
    4. Dexone
    5. DXM
    type
    DRUG
  4. arm Group Labels
    1. Arm A
    2. Arm B
    description
    Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3.
    name
    Stem cell collection
    other Names
    1. Stem Cell Mobilization
    type
    PROCEDURE
  5. arm Group Labels
    1. Arm A
    description
    Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
    name
    Melphalan
    other Names
    1. Evomela
    type
    DRUG
  6. arm Group Labels
    1. Arm A
    description
    Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
    name
    G-CSF
    other Names
    1. Granulocyte-colony stimulating factor (CSF)
    2. Filgrastim
    type
    DRUG
  7. arm Group Labels
    1. Arm A
    2. Arm B
    description
    Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
    name
    Cyclophosphamide
    other Names
    1. Cytophosphane
    type
    DRUG
  8. arm Group Labels
    1. Arm A
    2. Arm B
    description
    Mesna will be provided with the cyclophosphamide.
    name
    Mesna
    other Names
    1. Mesnex
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
60
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
    measure
    Complete Response Rate
    time Frame
    3 years
secondary Outcomes
  1. description
    To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
    measure
    Overall Survival Rate (OS)
    time Frame
    4 years
  2. description
    To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
    measure
    Overall Survival Rate (OS)
    time Frame
    2 years
  3. description
    PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
    measure
    Progression Free Survival (PFS)
    time Frame
    4 years
  4. description
    PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
    measure
    Progression Free Survival (PFS)
    time Frame
    2 years
Full study description
brief Summary
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
detailed Description
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000 deaths each year in the United States. Approximately one third of myeloma patients develop hypercalcemia and about two thirds present with anemia. As the second most common hematologic malignancy, myeloma remains incurable. In the last forty years, options for therapy have included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with those regimens continues to be inevitable with a median survival of 3 years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice