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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00526734
First received: September 5, 2007
Last updated: August 9, 2013
Last verified: September 2007

September 5, 2007
August 9, 2013
February 2006
Not Provided
Number of patients with engraftment after induction chemotherapy [ Designated as safety issue: No ]
Number of patients with engraftment after induction chemotherapy
Complete list of historical versions of study NCT00526734 on ClinicalTrials.gov Archive Site
  • Number and proportion of patients from whom ≥ 2 x 10e6 CD34-positive cells/kg are harvested [ Designated as safety issue: No ]
  • Number and proportion of patients from whom ≥ 4 x 10e6 CD34-positive cells/kg are harvested [ Designated as safety issue: No ]
  • CD34-positive cells/kg yield in each leukapheresis [ Designated as safety issue: No ]
  • Number of leukaphereses to collect ≥ 2 x 10e6 CD34-positive cells/kg [ Designated as safety issue: No ]
  • Number of leukaphereses to collect ≥ 4 x 10e6 CD34-positive cells/kg [ Designated as safety issue: No ]
  • Proportion of patients with platelet recovery ≥ 20 x 10e9/L in the absence of transfusion for at least 7 days [ Designated as safety issue: No ]
  • Proportion of patients with ANC recovery of ≥ 0.5 x 10e9/L [ Designated as safety issue: No ]
  • Time to neutrophil recovery, defined as the time to neutrophil engraftment (i.e., ANC ≥ 0.5 x 10e9/L for 3 consecutive days) [ Designated as safety issue: No ]
  • Time to ANC ≥ 1.0 x 10e9/L [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Incidence and duration of hospitalization during mobilization phase and during post-transplantation phase [ Designated as safety issue: No ]
  • Incidence and severity of adverse events during and after the use of pegfilgrastim 12 mg or pegfilgrastim 18 mg and filgrastim [ Designated as safety issue: Yes ]
  • 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
  • Proportion of patients with platelet recovery ≥ 20 x 10e9/L in the absence of transfusion for at least 7 days
  • Proportion of patients with ANC recovery of ≥ 0.5 x 10e9/L
  • Time to neutrophil recovery, defined as the time to neutrophil engraftment (i.e., ANC ≥ 0.5 x 10e9/L for 3 consecutive days)
  • Time to ANC ≥ 1.0 x 10e9/L
  • 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
  • Incidence and duration of hospitalization during mobilization phase and during post-transplantation phase
  • Incidence and severity of adverse events during and after the use of pegfilgrastim 12 mg or pegfilgrastim 18 mg and filgrastim
Not Provided
Not Provided
 
High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Multiple Myeloma
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)

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.

OBJECTIVES:

Primary

  • 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).

Secondary

  • 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.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Biological: filgrastim
  • Biological: pegfilgrastim
  • Drug: melphalan
  • Procedure: autologous hematopoietic stem cell transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

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

    • Newly diagnosed disease
  • No amyloidosis

PATIENT CHARACTERISTICS:

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

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
  • 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
Both
18 Years to 70 Years
No
Not Provided
Belgium,   Poland
 
NCT00526734
ERA-2006-001, CDR0000561733, ERA-NEUMOBIL, EUDRACT-2006-000891-34
Not Provided
Not Provided
Hopital Universitaire Erasme
Not Provided
Study Chair: Walter Feremans, MD, PhD Hopital Universitaire Erasme
National Cancer Institute (NCI)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP