Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients
Information source: Nordic Myeloma Study Group
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Fludarabine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Nordic Myeloma Study Group Official(s) and/or principal investigator(s): Hans E. Johnsen, Prof., MD, Principal Investigator, Affiliation: Aalborg Univeristy Hospital
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.
Clinical Details
Official title: Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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 outcome: 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.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
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Department of Haematology B, Aalborg Hospital, University of Aarhus, Aalborg 9000, Denmark
Department of Haematology, Herlev University Hospital, Herlev 2730, Denmark
Department of Haematology, Rigshospitalet, København Ø 2100, Denmark
Department of Haematology X, Odense University Hospital, Odense 5000, Denmark
Department of Haematology, Vejle Hospital, Vejle 7100, Denmark
Dept. of Haematology, Århus University Hospital, Århus 8000, Denmark
Additional Information
Starting date: May 2005
Last updated: September 28, 2006
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