NCT01453088 — Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older · CancerIndex
Clinical trial · Interventional
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
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).
interventionNames
Drug: Melphalan
type
EXPERIMENTAL
label
Treatment Arm B
description
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.
interventionNames
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
60 Years
Show eligibility criteria text
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
References
Publications (62)
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Drug: Bortezomib
Primary outcomes (1)
measure
Progression Free Survival Rate
timeFrame
Participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely
description
Progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib at 3 years
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