Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma
United States54 participantsStarted 2010-06-09
Plain-language summary
The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone.
Who can participate
Age range18 Years – 69 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:
* Diagnosis of multiple myeloma
* Have a suitable related or unrelated donor
* Age ≥18 but \<70 yrs
* KPS of ≥70%
* Recovery from complications of previous therapies
Exclusion Criteria:
* Diagnosis other than multiple myeloma
* Chemotherapy or radiotherapy within 21 days of initiating treatment in this study
* Prior dose-intense therapy requiring HSC support 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 \<50% of predicted and/or receiving supplementary continuous oxygen
* Evidence of hepatic synthetic dysfunction, or total bilirubin \>2x or AST \>3x ULN
* Measured creatinine clearance \<20 ml/min
* Sensory peripheral neuropathy grade 4 within 14 days of enrollment
* Karnofsky score \<70% unless a result of bone disease directly caused by myeloma
* Life expectancy limited by another co-morbid illness
* Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
* Female subject is pregnant or breast-feeding (women) or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment. Confirmation that…
What they're measuring
1
Progression Free Survival
Timeframe: Subjects will be followed for progression-free survival for at least 36 months