Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment fludarabine
Phase phase 2
Sponsor Nordic Myeloma Study Group
Start date May 2005
End date December 2006
Trial size 80 participants
Trial identifier NCT00382694, NMSG#13/03

Summary

Multiple myeloma is an incurable malignant disease which evnetuelly will relapse after primary treatment. Clonal B-cells have been identified and in theory these cells might be sleeping during primary treatment and be responsible for later relapse. Fluarabine has documented effect on both resting and dividing cells including B-cells. The protocol aim at evaluating safety and toxicity of adding fludarabine to induction chemotherapy with cyclophosphamide and dexamethasone before high-dose melphalan with autologous stem cell support.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
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).
time frame:

Secondary Outcomes

Measure
Quantification of clonal cells in bone marrow and blood by flow cytometry (MRD) and to study new potential prognostic markers identified by cytomic, genomic and proteomic analysis.
time frame:
Estimation of 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
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: - Multiple myeloma, stage I-III, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation. Exclusion Criteria: - Severe uncontrolled clinical or microbiological evidence of infection at the time of enrolment. - Other active malignancy. - Severe coincident heart or lung disease including uncontrolled hypertension, unstable angina, congestive heart failure, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled cardiac arrhythmia. - Other severe illness including poorly controlled diabetes. - Haemolytic anaemia (Coombs positive without evidence of haemolysis is accepted). - Idiopathic thrombocytopenic purpura. - Terminal illness. - Allogenic transplantation planned within 6 months. - Chemotherapy before inclusion. - Pregnancy or breast-feeding, or inadequate contraceptive precautions. - Psychiatric disease, abuse of alcohol or narcotics, or any other disorder that might compromise the patients ability to give informed consent.

Additional Information

Official title Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03
Principal investigator Hans E. Johnsen, Prof., MD
Description 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). OBJECTIVES: - 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 proteomic analysis. - 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by Nordic Myeloma Study Group.