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

SparkCures ID	141
Trial Phase	Phase 2
Enrollment	398 Patients
Treatments	Autologous Stem Cell Transplant Bortezomib Filgrastim Melphalan
Trial Sponsors	John Theurer Cancer Center at Hackensack University Medical Center
NCT Identifier	NCT01453088

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

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

Overview

Am I Eligible?

US Trial Locations