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

Overview

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
Trial Sponsors
  • 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified John Theurer Cancer Center<br />Hackensack Meridian Health

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New Jersey
Verified John Theurer Cancer Center<br />Hackensack Meridian Health

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Washington, D.C.

Resources

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