Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
NCT ID: NCT00540644
Last Updated: 2016-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2007-10-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Revlimid, Cyclophosphamide, Prednisone
Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.
Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.
Prednisone every other day orally.
lenalidomide (Revlimid®)
25 mg p.o. daily on days 1-21 of each 28 day cycle
Cyclophosphamide
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
Prednisone
50 mg p.o. Q.O.D.
Interventions
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lenalidomide (Revlimid®)
25 mg p.o. daily on days 1-21 of each 28 day cycle
Cyclophosphamide
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
Prednisone
50 mg p.o. Q.O.D.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma
PLUS one or more of the following:
* Calcium elevation (11.5 mg/dl) \[42.65 mmol/l\]
* Renal insufficiency (1.5 x the ULN of serum creatinine)
* Anemia (hemoglobin \<=10 g/dl or 2 g/dl \<= normal)
* Bone disease (lytic lesions or osteopenia)
Measurable disease is defined at least one of the following three measurements:
* Serum M-protein \>=1 g/dl ( or 10 g/l)
* Urine M-protein \>=200 mg/24 h
* Serum FLC assay: Involved FLC level \>=10 mg/dl (\>=100 mg/l) provided serum FLC ratio is abnormal
* Measurable plasmacytoma
* NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response.
Laboratory test results within these ranges:
* Absolute neutrophil count \>= 1.0 x 109/L
* Platelet count \>= 50 x 10(9)/L
* Hemoglobin \>= 9 gm/dl
* Serum creatinine \<= 2.5mg/dL.
* Total bilirubin \<=1.5 x upper limit of normal
* AST (SGOT) and ALT (SGPT) \<= 3 x ULN
Exclusion Criteria
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Patients with a solitary plasmacytoma
* Patients with uncontrolled diabetes
* Patients with ≥ Grade 3 sensory neuropathy
* History of cardiac disease, with NYHA Class II or greater
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Attaya Suvannasankha
OTHER
Responsible Party
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Attaya Suvannasankha
Assistant Professor of Medicine
Principal Investigators
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Attaya Suvannasankha, M.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University Cancer Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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0704-06; IUCRO-0170
Identifier Type: -
Identifier Source: org_study_id
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