Status:
TERMINATED
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Multiple Myeloma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01453088
Start Date
June 24 2010
End Date
May 1 2022
Last Update
November 28 2023
Active Locations (2)
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1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20057
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601