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


Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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).

Principal Investigator

Hans E. Johnsen, Prof., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aalborg Univeristy Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

NMSG#13/03

NCT ID:

NCT00382694

Start Date:

May 2005

Completion Date:

December 2006

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Induction therapy
  • High-dose melphalan
  • Autologous stem cell support
  • Fludarabine
  • Cyclophosphamide
  • Dexamethasone
  • Safety
  • Toxicity
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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