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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hackensack University Medical Center
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT01453088
First received: June 30, 2011
Last updated: August 27, 2014
Last verified: August 2014

June 30, 2011
August 27, 2014
June 2010
November 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01453088 on ClinicalTrials.gov Archive Site
To compare the response rate, overall survival and toxicity of high-dose melphalan versus high-dose melphalan and bortezomib [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
(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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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 Name: Phenylalanine mustard
  • 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 Name: Velcade
  • 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).

    Intervention: Drug: Melphalan
  • 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.

    Intervention: Drug: Bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
398
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Michele Donato, MD 201-996-5900 MDonato@humed.com
Contact: Marie Del Favero, RN 201-996-5828 MDelFavero@humed.com
United States
 
NCT01453088
PRO# 1307
Yes
Hackensack University Medical Center
Hackensack University Medical Center
Not Provided
Principal Investigator: Michele Donato, MD John Theurer Cancer Center at Hackensack University Medical Center
Hackensack University Medical Center
August 2014

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