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

NCT00540644 | Completed Phase 2 Results DMC

• 1 other identifier: 0704-06; IUCRO-0170
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Revlimid

Outcome Measures

Primary Outcomes (1)

• Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria

  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 Outcomes (2)

• Treatment Related Adverse Events Grade 3 or Higher

  Beginning of treatment up to 5 years

• Quality of Life Using the FACT-G Data

  baseline and after last cycle (up to 6 cycles)

Study Arms (1)

Revlimid, Cyclophosphamide, Prednisone

EXPERIMENTAL

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®); Drug: Cyclophosphamide; Drug: Prednisone

Interventions

lenalidomide (Revlimid®) DRUG

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

Also known as: Revlimid®

Revlimid, Cyclophosphamide, Prednisone

Cyclophosphamide DRUG

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

Revlimid, Cyclophosphamide, Prednisone

Prednisone DRUG

50 mg p.o. Q.O.D.

Revlimid, Cyclophosphamide, Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attaya Suvannasankha: lead
• Celgene: collaborator

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Cyclophosphamide; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Attaya Suvannasankha
• Organization: IndianaU

asuvanna@iu.edu

317-944-0920

Study Officials

• Attaya Suvannasankha, M.D.

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2014
• Last Updated: June 21, 2016
• Results First Posted: June 21, 2016

Record last verified: 2016-05

Locations

US (1)