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Trial record 12 of 794 for:    LENALIDOMIDE AND cells

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

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ClinicalTrials.gov Identifier: NCT01731886
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Suzanne Lentzsch, MD, Columbia University

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Procedure: Autologous peripheral blood stem cell transplant Drug: Lenalidomide Drug: Dexamethasone Procedure: Stem cell collection Drug: Melphalan Drug: G-CSF Drug: Cyclophosphamide Drug: Mesna Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
Actual Study Start Date : September 2012
Actual Primary Completion Date : April 11, 2017
Actual Study Completion Date : April 11, 2017


Arm Intervention/treatment
Active Comparator: Arm A
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).
Procedure: Autologous peripheral blood stem cell transplant
Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.

Drug: Lenalidomide
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Other Names:
  • CC-5013
  • Revlimid

Drug: Dexamethasone
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Other Names:
  • Decadron
  • Hexadrol
  • Dexameth
  • Dexone
  • DXM

Procedure: Stem cell collection
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.
Other Name: Stem Cell Mobilization

Drug: Melphalan
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.
Other Name: Evomela

Drug: G-CSF
Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
Other Names:
  • Granulocyte-colony stimulating factor (CSF)
  • Filgrastim

Drug: Cyclophosphamide
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Other Name: Cytophosphane

Drug: Mesna
Mesna will be provided with the cyclophosphamide.
Other Name: Mesnex

Active Comparator: Arm B
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).
Drug: Lenalidomide
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Other Names:
  • CC-5013
  • Revlimid

Drug: Dexamethasone
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Other Names:
  • Decadron
  • Hexadrol
  • Dexameth
  • Dexone
  • DXM

Procedure: Stem cell collection
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.
Other Name: Stem Cell Mobilization

Drug: Cyclophosphamide
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
Other Name: Cytophosphane

Drug: Mesna
Mesna will be provided with the cyclophosphamide.
Other Name: Mesnex




Primary Outcome Measures :
  1. Difference in complete response rate [ Time Frame: 3 years ]
    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


Secondary Outcome Measures :
  1. Difference in overall survival rate [ Time Frame: 3 years ]
    To compare overall survival and time to progression 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731886


Locations
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United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Suzanne Lentzsch, MD Columbia University

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Responsible Party: Suzanne Lentzsch, MD, Associate Clinical Professor of Clinical Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01731886     History of Changes
Obsolete Identifiers: NCT00777881
Other Study ID Numbers: AAAJ2355
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After completion of the study.
Access Criteria: All data will be coded with study identifiers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Suzanne Lentzsch, MD, Columbia University:
Stem cell transplant
plasma cell myeloma
multiple myeloma
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Lenalidomide
Multiple Myeloma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Melphalan
BB 1101
Mesna
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists