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Trial #NCT01453088
Multiple Myeloma Clinical Trials

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
Study ID: PRO# 1307; Source: Hackensack University Medical Center
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country United States
Study type Interventional
Enrollment 398
Start date June 2010
Completion date December 2014
Phase Phase 2
Sponsor Hackensack University Medical Center
Summary:
In this study the investigators are comparing this standard regimen to the newly established
regimen of melphalan and bortezomib.
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.
Eligibility:
Gender: Both
Age: 60 Years - N/A
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
Outcome:
Primary outcome
  • 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
Secondary outcome
  • To compare the response rate, overall survival and toxicity of high-dose melphalan versus high-dose melphalan and bortezomib
    Time frame: 1 year
Contacts:
  • Michele Donato, MD; John Theurer Cancer Center at Hackensack University Medical Center (Principal Investigator)
  • Marie Del Favero, RN;
    Phone: 201-996-5828
  • Michele Donato, MD;
    Phone: 201-996-5900
Location Country Status
Hackensack University Medical Center Hackensack, New Jersey United States Recruiting
Sponsors:
  • Hackensack University Medical Center - (Lead Sponsor)

Related trials: Terms
  • transplant
  • multiple myeloma
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