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

May 12, 2016 updated by: Attaya Suvannasankha

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

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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..

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Time Frame: After 6 cycles
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.
After 6 cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Related Adverse Events Grade 3 or Higher
Time Frame: Beginning of treatment up to 5 years
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Beginning of treatment up to 5 years
Quality of Life Using the FACT-G Data
Time Frame: baseline and after last cycle (up to 6 cycles)

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
baseline and after last cycle (up to 6 cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attaya Suvannasankha

Collaborators

Celgene

Investigators

  • Principal Investigator: Attaya Suvannasankha, M.D., Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0704-06; IUCRO-0170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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