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Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Fludarabine
Sponsored by
Nordic Myeloma Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Induction therapy, High-dose melphalan, Autologous stem cell support, Fludarabine, Cyclophosphamide, Dexamethasone, Safety, Toxicity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Haematology B, Aalborg Hospital, University of Aarhus
  • Department of Haematology, Herlev University Hospital
  • Department of Haematology, Rigshospitalet
  • Department of Haematology X, Odense University Hospital
  • Department of Haematology, Vejle Hospital
  • Dept. of Haematology, Århus University Hospital

Outcomes

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

Full Information

First Posted
September 28, 2006
Last Updated
September 28, 2006
Sponsor
Nordic Myeloma Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00382694
Brief Title
Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients
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 Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nordic Myeloma Study Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Induction therapy, High-dose melphalan, Autologous stem cell support, Fludarabine, Cyclophosphamide, Dexamethasone, Safety, Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fludarabine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans E. Johnsen, Prof., MD
Organizational Affiliation
Aalborg Univeristy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Haematology B, Aalborg Hospital, University of Aarhus
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Department of Haematology, Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Haematology, Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Haematology X, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Department of Haematology, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Dept. of Haematology, Århus University Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

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