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Trial record 33 of 2573 for:    "Plasma Cell Neoplasm"

High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526734
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 10, 2007
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: filgrastim Biological: pegfilgrastim Drug: melphalan Procedure: autologous hematopoietic stem cell transplantation Phase 2

Detailed Description:



  • Compare engraftment of peripheral blood progenitor cells (PBPCs) mobilized by 2 different fixed doses of pegfilgrastim versus a by-weight dose of filgrastim (G-CSF).


  • Determine the ability of 2 different fixed doses of pegfilgrastim to mobilize PBPCs.
  • Determine the safety of pegfilgrastim during PBPC mobilization and collection.
  • Determine the effect of different induction chemotherapy regimens on autologous progenitor cell transplantation.

OUTLINE: This is a multicenter study. Patients are stratified by type of induction chemotherapy (Thal/Dex vs VAD vs Vel-Dex vs VTD) and by stage of disease according to International Prognostic Index criteria (stage I [i.e., beta-2 microglobulin < 3.5 and albumin > 35] vs stages II and III).

  • Induction therapy: Patients receive 3-4 courses of 1 of the following regimens:

    • VAD: Patients receive vincristine, doxorubicin hydrochloride, and dexamethasone.
    • Thal/Dex: Patients receive thalidomide and dexamethasone.
    • Vel-Dex: Patients receive bortezomib and dexamethasone.
    • VTD: Patients receive bortezomib, thalidomide, and dexamethasone. Patients achieving complete, partial, or minimal response after 3-4 courses of induction therapy proceed to peripheral blood progenitor cell (PBPC) mobilization 17 days after completion of induction therapy.
  • PBPC mobilization: Patients are randomized to 1 of 3 arms.

    • Arm I: Patients receive filgrastim subcutaneously (SC) once daily until the final leukapheresis.
    • Arm II: Patients receive a single dose of pegfilgrastim SC.
    • Arm III: Patients receive pegfilgrastim as in arm II at a higher dose.
  • Leukapheresis: Patients undergo up to 3 leukaphereses to obtain adequate numbers of CD34-positive filgrastim- or pegfilgrastim-mobilized PBPCs for engraftment. Patients achieving a sufficient number of collected PBSCs proceed to conditioning chemotherapy.
  • Conditioning chemotherapy: Patients receive high-dose melphalan* IV over 1-2 days. Patients then proceed to PBPC transplantation.

NOTE: *Patients ≥ 65 years old receive melphalan at a lower dose.

  • Autologous PBPC transplantation: Patients undergo infusion of PBPCs on day 0. Patients in all arms receive G-CSF support beginning on day 1 after PBPC transplantation and continuing until blood counts recover for 3 consecutive days.

After completion of study therapy, patients are followed for up to 100 days post-transplantation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, International, Open-label, Phase II Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization and Engraftment With Pegfilgrastim or Filgrastim for Autologous Transplantation in Patients With Multiple Myeloma (MM)
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Primary Outcome Measures :
  1. Number of patients with engraftment after induction chemotherapy

Secondary Outcome Measures :
  1. Number and proportion of patients from whom ≥ 2 x 10e6 CD34-positive cells/kg are harvested
  2. Number and proportion of patients from whom ≥ 4 x 10e6 CD34-positive cells/kg are harvested
  3. CD34-positive cells/kg yield in each leukapheresis
  4. Number of leukaphereses to collect ≥ 2 x 10e6 CD34-positive cells/kg
  5. Number of leukaphereses to collect ≥ 4 x 10e6 CD34-positive cells/kg
  6. Proportion of patients with platelet recovery ≥ 20 x 10e9/L in the absence of transfusion for at least 7 days
  7. Proportion of patients with ANC recovery of ≥ 0.5 x 10e9/L
  8. Time to neutrophil recovery, defined as the time to neutrophil engraftment (i.e., ANC ≥ 0.5 x 10e9/L for 3 consecutive days)
  9. Time to ANC ≥ 1.0 x 10e9/L
  10. Time to platelet recovery, defined as the time to platelets ≥ 20 x 10e9/L in the absence of platelet transfusion support for at least 7 days
  11. Incidence and duration of hospitalization during mobilization phase and during post-transplantation phase
  12. Incidence and severity of adverse events during and after the use of pegfilgrastim 12 mg or pegfilgrastim 18 mg and filgrastim

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of symptomatic stage I or stage II-III multiple myeloma

    • Newly diagnosed disease
  • No amyloidosis


Inclusion criteria:

  • 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

Exclusion criteria:

  • 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


  • 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
  • No other concurrent G-CSF growth factors
  • No concurrent enrollment in another investigational clinical trial
  • No concurrent investigational agent that would contraindicate the use of pegfilgrastim as either a mobilization agent or a hematological recovery agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526734

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Hopital Universitaire Erasme Recruiting
Brussels, Belgium, 1070
Contact: Walter Feremans, MD, PhD    32-2-555-3660   
Medical University of Gdansk Recruiting
Gdansk, Poland, 80-211
Contact: Andrzej W. Hellmann, MD, PhD    48- 58-349-2230      
Silesian Medical Academy Recruiting
Katowice, Poland, 40-029
Contact: Jerzy Holowiecki, MD, PhD    48-32-256-2858   
Institute of Haematology and Blood Transfusion Recruiting
Warsaw, Poland, 00-957
Contact: Krzysztof Warzocha, MD, PhD    48-22-849-8507   
Sponsors and Collaborators
Erasme University Hospital
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Study Chair: Walter Feremans, MD, PhD Erasme University Hospital

Layout table for additonal information Identifier: NCT00526734     History of Changes
Other Study ID Numbers: ERA-2006-001
CDR0000561733 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: September 2007
Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic