Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

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Blood Protein Disorders

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Anti-Inflammatory Agents

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Gastrointestinal Agents

All Drugs and Chemicals

Antirheumatic Agents

Dexamethasone

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Dexamethasone acetate

Hans E. Johnsen, Prof., MD

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.

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.

Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

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

Nordic Myeloma Study Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients	NCT00382694	Multiple Myelom...	Fludarabine	18 Years - 64 Years	Nordic Myeloma Study Group
Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients	NCT00382694	Multiple Myelom...	Fludarabine	18 Years - 64 Years	Nordic Myeloma Study Group

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