Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myelom… (NCT01453088) | Clinical Trial Compass
TerminatedPhase 2
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
Stopped: Lack of Accrual
United States63 participantsStarted 2010-06-24
Plain-language summary
In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Progression Free Survival Rate
Timeframe: Participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely