Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsor:
Indiana University School of Medicine
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00540644
First received: October 5, 2007
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: lenalidomide (Revlimid®) Drug: Cyclophosphamide Drug: Prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Indiana University:
Primary Outcome Measures:
- Response Rate (RR) after 6 cycles of therapy using the proposed International Myeloma Working Group uniform response criteria [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The biologic effect of the RCP regimen on bone turnover markers. [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- The biologic effect of the RCP regimen on serum cytokine profiling [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Safety (type, frequency, severity, and relationship of adverse events to study treatment) [ Time Frame: assessed every 4 weeks ] [ Designated as safety issue: Yes ]
- Quality of life using the FACT-G data [ Time Frame: baseline, after 3 cycles, after 6 cycles ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Drug: lenalidomide (Revlimid®)
25 mg p.o. daily on days 1-21 of each 28 day cycle
Other Name: Revlimid®
Drug: Cyclophosphamide
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
Drug: Prednisone
50 mg p.o. Q.O.D.
|
Detailed Description:
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. 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..
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients with newly diagnosed, symptomatic multiple myeloma based on the following 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:
- Known hypersensitivity to thalidomide
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540644
Locations
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
Sponsors and Collaborators
Indiana University School of Medicine
Celgene Corporation
Investigators
| Principal Investigator: | Attaya Suvannasankha, M.D. | Indiana University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Indiana University ( Indiana University School of Medicine ) |
| ClinicalTrials.gov Identifier: | NCT00540644 History of Changes |
| Other Study ID Numbers: | 0704-06; IUCRO-0170 |
| Study First Received: | October 5, 2007 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Indiana University:
|
Multiple Myeloma Revlimid |
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 Cyclophosphamide |
Lenalidomide Prednisone Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on June 18, 2013