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

This study has been completed.
Sponsor:
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: September 18, 2014
Last verified: September 2014
  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
Study Completion Date: August 2014
Primary Completion Date: December 2012 (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
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, see Learn About Clinical Studies.

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

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: September 18, 2014
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Cyclophosphamide
Lenalidomide
Prednisone
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Glucocorticoids
Growth Inhibitors
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 29, 2014