Clinical Trials /

Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older

NCT01453088

Description:

In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
  • Official Title: (PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older

Clinical Trial IDs

  • ORG STUDY ID: PRO# 1307
  • NCT ID: NCT01453088

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
MelphalanPhenylalanine mustardTreatment A
BortezomibVelcadeTreatment Arm B

Purpose

In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.

Detailed Description

      In this study the investigators are comparing this standard regimen to the newly established
      regimen of melphalan and bortezomib.

      Conditioning Regimens:

      Treatment arm A Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion
      via a central or peripheral vein over 30 minutes to one hour.

      Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.

      Dosing will be based on body surface area calculated using actual body weight

      Stem cell infusion:

      Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of
      melphalan. The infusion of peripheral blood stem cells will be done in accordance with the
      Blood and Marrow Transplant program standard operating procedures.

      Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day
      starting on day+3 then daily starting on day 9 until engraftment (at least).

      Treatment arm B

      Bortezomib:

      Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral
      vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at
      least 20 hrs after the start of the melphalan infusion on day -1.

      Dosing will be based on actual body weight. Dexamethasone is administered at a dose of 20 mg
      IV prior to each bortezomib infusion.

      Melphalan:

      Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central
      or peripheral vein over 30 minutes to one hour.

      Melphalan will be given as a single dose (not split over 2 or more days) and given of day-2.

      Dosing will be based body surface area calculated using actual body weight

      Stem cell infusion:

      Stem cell infusion will occur on day 0 and will be at least 18 hours after the infusion of
      the bortezomib. The infusion of peripheral blood stem cells will be done in accordance with
      the Blood and Marrow Transplant program standard operating procedures.

      Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day
      starting on day+3 then daily starting on day 9 until engraftment (at least).

      Post-transplant Supportive Care will be administered in accordance to the Blood and Marrow
      Transplant program standard operating procedures.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment AActive ComparatorMelphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour. Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1. Dosing will be based on body surface area calculated using actual body weight Stem cell infusion: Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures. Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).
  • Melphalan
Treatment Arm BExperimentalBortezomib: Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
  • Bortezomib

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma less than 12 months since initiation of
             systemic therapy

          -  Age ≥60 years at time of transplantation

          -  KPS 70-100%

          -  Recovery from complications of prior therapy

        Exclusion Criteria:

          -  Diagnosis other than multiple myeloma

          -  Chemotherapy or radiotherapy within 8 days of initiating treatment in this study

          -  Prior dose-intense therapy within 56 days of initiating treatment in this study

          -  Uncontrolled bacterial, viral, fungal or parasitic infections

          -  Uncontrolled CNS metastases

          -  Known amyloid deposition in heart

          -  Organ dysfunction

          -  LVEF <40% or cardiac failure not responsive to therapy

          -  FVC, FEV1 or DLCO < 40% of predicted and/or receiving supplementary continuous oxygen

          -  Evidence of hepatic synthetic dysfunction or total bilirubin > 2x or AST > 3x ULN

          -  Measured creatinine < 20ml/min

          -  Sensory peripheral neuropathy grade 4 within 14 days of enrollment

          -  Karnofsky score < 70%

          -  Life expectancy limited by other co-morbid illnesses
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To compare the progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib.
Time Frame:Participants will be followed post transplant for a minimum of 2 years, and after that may be monitored as part of the study indefinitely
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To compare the response rate, overall survival and toxicity of high-dose melphalan versus high-dose melphalan and bortezomib
Time Frame:1 year
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hackensack Meridian Health

Trial Keywords

  • multiple myeloma
  • transplant

Last Updated

August 16, 2019