Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

Sponsor

Nordic Myeloma Study Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00382694

Collaborator

(none)

Enrollment

Locations

Duration (Months)

13.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Fludarabine	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

May 1, 2005

Study Completion Date :

Dec 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Haematology B, Aalborg Hospital, University of Aarhus	Aalborg	Denmark	9000
2	Department of Haematology, Herlev University Hospital	Herlev	Denmark	2730
3	Department of Haematology, Rigshospitalet	København Ø	Denmark	2100
4	Department of Haematology X, Odense University Hospital	Odense	Denmark	5000
5	Department of Haematology, Vejle Hospital	Vejle	Denmark	7100
6	Dept. of Haematology, Århus University Hospital	Århus	Denmark	8000