NCT00382694

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 29, 2006

Status Verified

September 1, 2006

First QC Date

September 28, 2006

Last Update Submit

September 28, 2006

Conditions

Multiple Myeloma

Keywords

MyelomaInduction therapyHigh-dose melphalanAutologous stem cell supportFludarabineCyclophosphamideDexamethasoneSafetyToxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Interventions

FludarabineDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Multiple myeloma, stage I-III, previously untreated, and eligible for induction therapy followed by high dose treatment supported by autologous stem cell transplantation.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Haematology B, Aalborg Hospital, University of Aarhus

Aalborg, 9000, Denmark

Location

Dept. of Haematology, Århus University Hospital

Aarhus, 8000, Denmark

Location

Department of Haematology, Herlev University Hospital

Herlev, 2730, Denmark

Location

Department of Haematology, Rigshospitalet

København Ø, 2100, Denmark

Location

Department of Haematology X, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Haematology, Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Hans E. Johnsen, Prof., MD

    Aalborg Univeristy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

May 1, 2005

Study Completion

December 1, 2006

Last Updated

September 29, 2006

Record last verified: 2006-09

Locations

DK(6)