Phase 2
Completed N=70
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov NCT00540644 ↗Enrolled (actual)
70
Serious AEs
24.3%
Results posted
Jun 2016
Primary outcomePrimary: Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria — 86.7; 71.4 percentage of participants
Summary
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria |
86.7; 71.4 | — |
| SECONDARY Treatment Related Adverse Events Grade 3 or Higher |
21; 11 | — |
| SECONDARY Quality of Life Using the FACT-G Data |
1.57; -2.81; -0.03; -0.23; 2.52; 0.60 | — |
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 =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
Data sourced from ClinicalTrials.gov (NCT00540644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.