Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively
      randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1)
      or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be
      randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was
      scheduled for all patients.
    

Detailed description: 
      In arm A1, patients received 4 cycles of conventional induction therapy with
      anthracycline/dexamethasone-based regimens. Specified in the protocol were
      vincristine/doxorubicin/dexamethasone (VAD), idarubicin/dexamethasone (ID) and
      cyclophosphamide/doxorubicin/dexamethasone (CAD). In arm A2, patients were planned to receive
      only dexamethasone 40 mg orally on days 1-4 and 8-11 for symptom control before stem cell
      mobilization. For the patients in arm B, a maximum of 6 cycles of induction chemotherapy was
      allowed. Following this, the treatment was identical for all patients. For stem cell
      mobilization, an age-adjusted IEV-regimen with granulocyte-colony stimulating factor (G-CSF)
      was recommended. The target dose for stem cell collection was 6 x 10E+6 CD34 (cluster of
      differentiation 34)-positive cells/kg (2 transplants and one back-up). The standard dose for
      each transplantation was 2 x 10E+6 CD34-positive cells/kg. High-dose melphalan at a total
      dose of 140 mg/m² (MEL140) was given in two doses of 70 mg/m² on days -3 and -2. Stem cell
      transplantation (SCT) was performed on day 0. A second MEL140 course was planned two months
      after the first. Regular bisphosphonate treatment was recommended.
    

Intervention name(s): Anthracycline/dexamethasone-based induction chemotherapy; Dexamethasone for control of symptoms; Tumor-reduction chemotherapy and stem cell mobilization; Stem cell apheresis; Tandem high-dose chemotherapy (melphalan); Autologous peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Procedure; Drug; Procedure
Intervention description(s): 4 cycles of anthracycline/dexamethasone-based chemotherapy; 2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg); Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc); stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 * 10E6/kg; Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²); Two infusions of collected stem cells (day 0: 2*10E6 CD34-cell/kg per transplantation)
Other intervention name(s): ID, VAD, CAD; dexamethasone; IEV + G-CSF; SC-apheresis; Tandem melphalan; PBSCT
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Melphalan; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high-dose chemotherapy; autologous blood stem-cell transplantation; induction chemotherapy; elderly patients