Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Indiana University School of Medicine Celgene Corporation
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00540644

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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Cyclophosphamide Prednisone Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma

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 ]

Estimated Enrollment:	48
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

25 mg p.o. daily on days 1-21 of each 28 day cycle

50 mg p.o. BID daily on days 1-21 of each 28 day cycle

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 (411.5 mg/dl) [42.65 mmol/l]
Renal insufficiency (creatinine 42 mg/dl) [177 mmol/l or more]
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)a
Urine M-protein >=200 mg/24 hb
Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio is abnormal
Measurable plasmacytoma

Laboratory test results within these ranges:

Absolute neutrophil count >= 1.0 x 109/L
Platelet count >= 50 x 109/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

Contacts

Contact: Cathy Patrick, R.N.	317-278-4184	cpatrick@iupui.edu
Contact: Attaya Suvannasankha, M.D.	317-274-0843	asuvanna@iupui.edu

Locations

United States, Indiana
Indiana University Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Cathy Patrick, R.N. 317-278-4184 cpatrick@iupui.edu
Contact: Attaya Suvannasankha, M.D. 317-274-0843 asuvanna@iupui.edu
Principal Investigator: Attaya Suvannasankha, M.D.

Sponsors and Collaborators

Indiana University School of Medicine

Celgene Corporation

Investigators

Principal Investigator:

Attaya Suvannasankha, M.D.

Indiana University School of Medicine

More Information

'Click: Multiple Myeloma/Plasma Cell Neoplasm' This link exits the ClinicalTrials.gov site

Responsible Party:	Indiana University Cancer Center ( Attaya Suvannasankha, MD/ Principal Investigator )
Study ID Numbers:	0704-06; IUCRO-0170
Study First Received:	October 5, 2007
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00540644
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

Multiple Myeloma
Revlimid

Study placed in the following topic categories:

Prednisone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias

Cyclophosphamide
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009