Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Nordic Myeloma Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nordic Myeloma Study Group
ClinicalTrials.gov Identifier:
NCT00382694
First received: September 28, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: Fludarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Nordic Myeloma Study Group:

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: 80
Study Start Date: May 2005
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382694

Locations
Denmark
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
Sponsors and Collaborators
Nordic Myeloma Study Group
Investigators
Principal Investigator: Hans E. Johnsen, Prof., MD Aalborg Univeristy Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382694     History of Changes
Other Study ID Numbers: NMSG#13/03
Study First Received: September 28, 2006
Last Updated: September 28, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Nordic Myeloma Study Group:
Myeloma
Induction therapy
High-dose melphalan
Autologous stem cell support
Fludarabine
Cyclophosphamide
Dexamethasone
Safety
Toxicity

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Fludarabine
Fludarabine phosphate
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014