NCT00526734

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps stem cells move from the bone marrow to the blood so they can be collected. It is not yet known which regimen is more effective in treating multiple myeloma. PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or stage III multiple myeloma.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

4 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

February 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
Last Updated

August 12, 2013

Status Verified

September 1, 2007

First QC Date

September 5, 2007

Last Update Submit

August 9, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Number of patients with engraftment after induction chemotherapy

Secondary Outcomes (12)

  • Number and proportion of patients from whom ≥ 2 x 10e6 CD34-positive cells/kg are harvested

  • Number and proportion of patients from whom ≥ 4 x 10e6 CD34-positive cells/kg are harvested

  • CD34-positive cells/kg yield in each leukapheresis

  • Number of leukaphereses to collect ≥ 2 x 10e6 CD34-positive cells/kg

  • Number of leukaphereses to collect ≥ 4 x 10e6 CD34-positive cells/kg

  • +7 more secondary outcomes

Interventions

filgrastimBIOLOGICAL
pegfilgrastimBIOLOGICAL
melphalanDRUG
autologous hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0-2
  • ANC ≥ 1.0 x 10\^9/L (without colony-stimulating factors)
  • Platelet count ≥ 50 x 10\^9/L (without transfusion support within the past 7 days)
  • Serum calcium \< 14 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • Willing and able to comply with protocol requirements

You may not qualify if:

  • Myocardial infarction within the past 6 months
  • New York Heart Association class III or IV heart failure
  • Uncontrolled angina
  • Severe uncontrolled ventricular arrhythmia
  • Acute ischemia or active conduction system abnormalities as evidenced by ECG
  • Serious medical condition that could prolong hematological recovery or preclude completion of or tolerance to protocol therapy
  • Seropositive for HIV antibody
  • Known hepatitis B surface antigen positivity OR active hepatitis C infection
  • Active systemic infection requiring treatment
  • Pregnant or nursing
  • Poor psychiatric condition
  • PRIOR CONCURRENT THERAPY:
  • No plasmapheresis within the past 4 weeks
  • No major surgery within the past 4 weeks
  • No anticancer therapy within the past 5 years, except treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Universitaire Erasme

Brussels, 1070, Belgium

RECRUITING

Medical University of Gdansk

Gdansk, 80-211, Poland

RECRUITING

Silesian Medical Academy

Katowice, 40-029, Poland

RECRUITING

Institute of Haematology and Blood Transfusion

Warsaw, 00-957, Poland

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

FilgrastimpegfilgrastimMelphalan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Walter Feremans, MD, PhD

    Erasme University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 10, 2007

Study Start

February 1, 2006

Last Updated

August 12, 2013

Record last verified: 2007-09

Locations

BE(1)PL(3)