Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments autologous peripheral blood stem cell transplant, lenalidomide, dexamethasone, stem cell mobilization
Phase phase 4
Sponsor Columbia University
Start date September 2012
End date February 2017
Trial size 60 participants
Trial identifier NCT01731886, AAAJ2355

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Lenalidomide and dexamethasone for four 28-day cycles, and stem cell mobilization, followed by autologous peripheral blood stem cell transplant followed by maintenance.
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.
lenalidomide CC-5013, Revlimid
ARM A Administered orally at a dose 25 mg daily on days 1-21 of each cycle. ARM B Administered orally at a dose 25 mg daily on days 1-21 of each cycle for 8 cycles. After cycle four, subjects will have peripheral stem cell collection. The final four cycles of lenalidomide and dexamethasone will be started within 4 weeks after stem cell collection.
dexamethasone Decadron, Hexadrol, Dexameth, Dexone, DXM
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
stem cell mobilization
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.
(Active Comparator)
Lenalidomide and dexamethasone for six to eight 28-day cycles, and stem cell mobilization, followed by maintenance.
lenalidomide CC-5013, Revlimid
ARM A Administered orally at a dose 25 mg daily on days 1-21 of each cycle. ARM B Administered orally at a dose 25 mg daily on days 1-21 of each cycle for 8 cycles. After cycle four, subjects will have peripheral stem cell collection. The final four cycles of lenalidomide and dexamethasone will be started within 4 weeks after stem cell collection.
dexamethasone Decadron, Hexadrol, Dexameth, Dexone, DXM
Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
stem cell mobilization
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.

Primary Outcomes

Measure
Difference in complete response rate
time frame: 3 years

Secondary Outcomes

Measure
Difference in overall survival rate
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Suzanne Lentzsch, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Columbia University.