Status:
COMPLETED
Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy) or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also lower blood count...
Eligibility Criteria
Inclusion
- Age ≥18 and \< than or = to 75
- Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines (Durie et al, 2003) .
- Patients must have symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease):
- Patients who are receiving high-dose melphalan and ASCT as part of their initial therapy require at least minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008)
- Patients who are receiving high-dose melphalan and ASCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008).
- There is no limit on the number of prior regimens received by the patient.
- Patients must have at least 7 x 10\^6 (+/- 0.5 x 10\^6) CD34+ stem cells/kg frozen if he/she is being treated as part of a salvage (second) transplant strategy; patients must have 10 x 10\^6 (+/- 0.5 x 10\^6) CD34+ stem cells/kg frozen if ASCT is being performed as part of initial therapy.
- Adequate organ function is required, defined as follows:
- Serum bilirubin ≤ 2.0 mg/dl
- AST, ALT and alkaline phosphatase \< 3 times the upper limit of laboratory normal
- Creatinine clearance \> or = to 40 ml/min (24 hour urine collection or calculated\*)
- \*To be calculated by the Cockroft-Gault method: (140-Age) x Mass (kg) x \[0.85 if female\] (72 x Creatinine (mg/dL)
- LVEF \> or = to 45% by MUGA or rest ECHO
- Diffusing capacity \> or = to 45% (adjusted for hemoglobin) predicted by pulmonary function testing
- Performance status KPS \> or = to 70%.
Exclusion
- Unstable angina or myocardial infarction within 4 months of initiating therapy on trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Pregnant or lactating females
- Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Contraindication to melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
- Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01416246
Start Date
August 1 2011
End Date
April 1 2016
Last Update
April 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065