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
Recruitment status was Active, not recruiting
Sponsor:
Nordic Myeloma Study Group
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
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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 |
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 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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Fludarabine Fludarabine monophosphate Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013