Clinical trial NCT01453088: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: multiple myeloma
transplant
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
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
Secondary outcomes:
measure: Overall Survival Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: John Theurer Cancer Center at Hackensack University Medical Center
name: Michele Donato, MD
role: PRINCIPAL_INVESTIGATOR
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