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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01731886
First Posted: November 22, 2012
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suzanne Lentzsch, MD, Columbia University
  Purpose
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 Intervention Phase
Multiple Myeloma Procedure: Autologous peripheral blood stem cell transplant Drug: Lenalidomide Drug: Dexamethasone Procedure: Stem cell collection Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Suzanne Lentzsch, MD, Columbia University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 12
Actual Study Start Date: September 2012
Study Completion Date: April 11, 2017
Primary Completion Date: April 11, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2, and will undergo autologous peripheral blood stem cell transplantation on day 0. Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
Drug: Lenalidomide
Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
Other Name: CC-5013, Revlimid
Drug: Dexamethasone
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Other Name: Decadron, Hexadrol, Dexameth, Dexone, DXM
Procedure: Stem cell collection
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously with mesna at a total of 2.4 gm/m2 intravenously or orally divided over 3 doses. Subjects then will receive mobilization using daily filgrastim (G-CSF) at 10 mcg/kg subcutaneously starting 24 hours after cyclophosphamide is completed and until stem cell collection. The use of AMD3100 (Plerixafor) is permitted. Peripheral stem cell collection will be performed at marrow recovery, usually when WBC is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
Other Name: Stem Cell Mobilization
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 Name: CC-5013, Revlimid
Drug: Dexamethasone
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
Other Name: Decadron, Hexadrol, Dexameth, Dexone, DXM
Procedure: Stem cell collection
Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously with mesna at a total of 2.4 gm/m2 intravenously or orally divided over 3 doses. Subjects then will receive mobilization using daily filgrastim (G-CSF) at 10 mcg/kg subcutaneously starting 24 hours after cyclophosphamide is completed and until stem cell collection. The use of AMD3100 (Plerixafor) is permitted. Peripheral stem cell collection will be performed at marrow recovery, usually when WBC is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
Other Name: Stem Cell Mobilization

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 IgG or .5 g/dL 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.
  • 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
    • AST(SGOT) / ALT(SGPT) < or = 2.5 X 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 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or TWO 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. 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.
  Contacts and Locations
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
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Suzanne Lentzsch, MD Columbia University
  More Information

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 Submitted: November 19, 2012
First Posted: November 22, 2012
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Multiple Myeloma
Neoplasms, Plasma Cell
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 acetate
Dexamethasone
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents