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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540644
• Other study ID #: 0704-06; IUCRO-0170
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2007
• Last updated: September 18, 2014
• Start date: October 2007
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• lenalidomide (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.

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (RR) after 6 cycles of therapy using the proposed International Myeloma Working Group uniform response criteria		6 cycles	No
Secondary	The biologic effect of the RCP regimen on bone turnover markers.		baseline, 3 months, 6 months	No
Secondary	The biologic effect of the RCP regimen on serum cytokine profiling		baseline, 3 months, 6 months	No
Secondary	Safety (type, frequency, severity, and relationship of adverse events to study treatment)		assessed every 4 weeks	Yes
Secondary	Quality of life using the FACT-G data		baseline, after 3 cycles, after 6 cycles	No

External Links

•   'Click: Multiple Myeloma/Plasma Cell Neoplasm'