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

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01453088
Collaborator
(none)
62
2
2
154.2
31
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 24, 2010
Actual Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment 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).

Drug: 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 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).
Other Names:
  • Phenylalanine mustard
  • Experimental: 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.

    Drug: Bortezomib
    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.
    Other Names:
  • Velcade
  • Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. To compare the response rate, overall survival and toxicity of high-dose melphalan versus high-dose melphalan and bortezomib [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia United States 20057
    2 Hackensack University Medical Center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health

    Investigators

    • Principal Investigator: Michele Donato, MD, John Theurer Cancer Center at Hackensack University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT01453088
    Other Study ID Numbers:
    • PRO# 1307
    First Posted:
    Oct 17, 2011
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Hackensack Meridian Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 9, 2022