Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

Official title:

Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00382694
• Other study ID #: NMSG#13/03
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 28, 2006
• Last updated: September 28, 2006
• Start date: May 2005
• Est. completion date: December 2006

Study information

• Verified date: September 2006
• Source: Nordic Myeloma Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Fludarabine

Locations

Country	Name	City	State
Denmark	Department of Haematology B, Aalborg Hospital, University of Aarhus	Aalborg
Denmark	Dept. of Haematology, Århus University Hospital	Århus
Denmark	Department of Haematology, Herlev University Hospital	Herlev
Denmark	Department of Haematology, Rigshospitalet	København Ø
Denmark	Department of Haematology X, Odense University Hospital	Odense
Denmark	Department of Haematology, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Myeloma Study Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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