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

This study has been completed.
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Attaya Suvannasankha, Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT00540644
First received: October 5, 2007
Last updated: May 12, 2016
Last verified: May 2016
  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: After 6 cycles ] [ Designated as safety issue: No ]
    Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.


Secondary Outcome Measures:
  • Treatment Related Adverse Events Grade 3 or Higher [ Time Frame: Beginning of treatment up to 5 years ] [ Designated as safety issue: Yes ]
    Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

  • Quality of Life Using the FACT-G Data [ Time Frame: baseline and after last cycle (up to 6 cycles) ] [ Designated as safety issue: No ]

    Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.

    Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome



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   (Adult, Senior)
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
Attaya Suvannasankha
Celgene
Investigators
Principal Investigator: Attaya Suvannasankha, M.D. Indiana University School of Medicine
  More Information

Additional Information:
Responsible Party: Attaya Suvannasankha, Assistant Professor of Medicine, 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
Results First Received: April 5, 2016
Last Updated: May 12, 2016
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
Thalidomide
Lenalidomide
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on August 23, 2016