DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Fludarabine Added to Induction Treatment in Untreated Multiple Myeloma Patients

Information source: Nordic Myeloma Study Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Fludarabine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Nordic Myeloma Study Group

Official(s) and/or principal investigator(s):
Hans E. Johnsen, Prof., MD, Principal Investigator, Affiliation: Aalborg Univeristy Hospital

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.

Clinical Details

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

Primary outcome: 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:

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

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

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Locations and Contacts

Department of Haematology B, Aalborg Hospital, University of Aarhus, Aalborg 9000, Denmark

Department of Haematology, Herlev University Hospital, Herlev 2730, Denmark

Department of Haematology, Rigshospitalet, København Ø 2100, Denmark

Department of Haematology X, Odense University Hospital, Odense 5000, Denmark

Department of Haematology, Vejle Hospital, Vejle 7100, Denmark

Dept. of Haematology, Århus University Hospital, Århus 8000, Denmark

Additional Information

Starting date: May 2005
Last updated: September 28, 2006

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017