Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients - Full Text View

Sponsored by:	Nordic Myeloma Study Group
Information provided by:	Nordic Myeloma Study Group
ClinicalTrials.gov Identifier:	NCT00382694

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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Cyclophosphamide Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Melphalan Fludarabine Fludarabine monophosphate Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients: A Randomised, Placebo Controlled, Double Blind Phase II Trial: NMSG #13/03

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

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

Locations

Denmark
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
Dept. of Haematology, Århus University Hospital
Århus, Denmark, 8000
Department of Haematology, Vejle Hospital
Vejle, Denmark, 7100
Department of Haematology B, Aalborg Hospital, University of Aarhus
Aalborg, Denmark, 9000

Sponsors and Collaborators

Nordic Myeloma Study Group

Investigators

Principal Investigator:

Hans E. Johnsen, Prof., MD

Aalborg Univeristy Hospital

More Information

Study ID Numbers:	NMSG#13/03
Study First Received:	September 28, 2006
Last Updated:	September 28, 2006
ClinicalTrials.gov Identifier:	NCT00382694
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

Study placed in the following topic categories:

Dexamethasone
Melphalan
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Fludarabine monophosphate

Cyclophosphamide
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Fludarabine
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009