Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03
This is a randomised, placebo controlled, phase II study evaluating toxicity and safety of
fludarabine added to CyDex (cyclophosphamide+dexamethasone) as induction therapy in younger
patients with untreated and treatment demanding multiple myeloma. The treatment regimen
Patients will be randomised at diagnosis either to CyDex + Placebo (control Arm A) or CyDex
+ Fludarabine (Experimental Arm B).
- Primary:To determine the toxicity and safety of fludarabine when added to induction
therapy by registration of side effects and adverse events in accordance with the
common toxicity criteria (CTC).
- Secondary:To quantitate clonal cells in bone marrow and blood by flow cytometry
(MRD)and to study new potential prognostic markers identified by cytomic, genomic and
- Tertiary: To estimate the efficacy of fludarabine when added to induction
chemotherapy(CyDex) in patients with multiple myeloma by clinical end points: disease
response and progression free survival.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The toxicity and safety of Fludarabine when added to induction therapy by registration of side effects and adverse events in accordance with the common toxicity criteria (CTC).
Hans E. Johnsen, Prof., MD
Aalborg Univeristy Hospital
Denmark: Danish Medicines Agency