Clinical trial NCT00540644: Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
Official title: Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Revlimid
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2007-10-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
timeFrame: After 6 cycles
Secondary outcomes:
measure: Treatment Related Adverse Events Grade 3 or Higher
timeFrame: Beginning of treatment up to 5 years
measure: Quality of Life Using the FACT-G Data
timeFrame: baseline and after last cycle (up to 6 cycles)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Attaya Suvannasankha, M.D.
role: PRINCIPAL_INVESTIGATOR
References: