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

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT01453088

Run by

Hackensack Meridian Health

People needed

63

Starts

2010-06-24

Expected to finish

2022-05-01

Last updated by the study team

2026-03-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lombardi Comprehensive Cancer Center at Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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