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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hackensack Meridian Health; Hackensack University Medical Center
• Treatments: Bortezomib; Melphalan

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