Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma
Condition: DS Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line
      stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy
      before a peripheral blood stem cell transplant may stop the growth of cancer cells by
      stopping them from dividing or killing them. After treatment, stem cells are collected from
      the patient's blood and stored. The stem cells are then returned to the patient to replace
      the blood-forming cells that were destroyed by the chemotherapy.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the complete response rate as defined by the International Myeloma Working
      Group (IMWG) criteria for patients with multiple myeloma treated with high dose chemotherapy
      with pharmacokinetic (PK) directed intravenous (IV) busulfan, bortezomib and melphalan
      (Bu/BTZ/Mel140) followed by autologous hematopoietic stem cell transplantation (ASCT) as
      first line therapy.

      SECONDARY OBJECTIVES:

      I. To determine the overall response rate of the regimen Bu/BTZ/Mel140. II. To determine the
      treatment related toxicity and mortality of the regimen, including 100-day mortality rates.

      III. To determine the duration of response, time to progression, progression-free survival,
      event-free survival and overall survival for this conditioning regimen.

      IV. To determine whether there is a gender or race difference in the pharmacokinetic profile
      of IV busulfan.

      V. To determine methylation and gene expression signatures of pre-treatment bone marrow
      plasma cells and explore associations of these signatures with outcome.

      OUTLINE:

      CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over
      20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.

      TRANSPLANT: Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day
      0.

      After completion of study treatment, patients are followed up for up to 5 years.
    

Intervention name(s): Busulfan; Melphalan; Bortezomib; Autologous Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): Given IV; Given IV; Given IV; Undergo autologous PBSCT; Undergo autologous PBSCT
Other intervention name(s): Alkeran; Autologous Stem Cell Transplantation; PBPC transplantation; Peripheral Blood Progenitor Cell Transplantation; Peripheral Stem Cell Support; Peripheral Stem Cell Transplantation
Intervention MeSH terms: Bortezomib; Melphalan; Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment