Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Nordic Myeloma Study Group.
Recruitment status was: Active, not recruiting
Information provided by:
Nordic Myeloma Study Group
First received: September 28, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03
Primary Outcome Measures:
- 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 Measures:
- 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
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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 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.
|Ages Eligible for Study:
||18 Years to 64 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Multiple myeloma, stage I-III, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00382694
|Department of Haematology B, Aalborg Hospital, University of Aarhus
|Aalborg, Denmark, 9000 |
|Department of Haematology, Herlev University Hospital
|Herlev, Denmark, 2730 |
|Department of Haematology, Rigshospitalet
|København Ø, Denmark, 2100 |
|Department of Haematology X, Odense University Hospital
|Odense, Denmark, 5000 |
|Department of Haematology, Vejle Hospital
|Vejle, Denmark, 7100 |
|Dept. of Haematology, Århus University Hospital
|Århus, Denmark, 8000 |
Nordic Myeloma Study Group
||Hans E. Johnsen, Prof., MD
||Aalborg Univeristy Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2006
||September 28, 2006
||Denmark: Danish Medicines Agency
Keywords provided by Nordic Myeloma Study Group:
Autologous stem cell support
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs