Status:
COMPLETED
PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation
Lead Sponsor:
Acrotech Biopharma Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transpl...
Detailed Description
This study will be a multicenter, open-label, randomized, comparative, cross-over study of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection conducted in 24 patie...
Eligibility Criteria
Inclusion
- Patients with symptomatic MM requiring treatment at diagnosis or anytime thereafter.
- Patients with MM who qualify for ASCT therapy who have received appropriate primary induction therapy for transplantation.
- Adult patients (≥ 18 years old) who are 70 years of age or younger at time of transplant; patients greater than 70 years of age may qualify on a case-by-case basis if the patient meets local institutional criteria to receive a total melphalan dose of 200 mg/m2 as a conditioning regimen and if approved by the Medical Monitor.
- Patients with an adequate autologous graft which is defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 × 106 CD34+ cells/kg based upon patient weight.
- Patients with adequate organ function as measured by:
- Cardiac: Left ventricular ejection fraction at rest \>40% (documented within 12 weeks prior to Day -3).
- Hepatic: Bilirubin \<2 × the upper limit of normal (ULN) and ALT/AST \<3 × ULN.
- Renal: Creatinine clearance \>40 mL/minutes (measured or calculated/estimated).
- Pulmonary: DLCO, FEV1, FVC \>50% of predicted value (corrected for Hgb) or O2 saturation \> 92% on room air (documented within 12 weeks prior to Day -3)
Exclusion
- Patients who have never advanced beyond Stage 1 MM since diagnosis.
- Patients who have previously received more than one autologous stem cell transplant.
- Patients with plasma cell leukemia.
- Patients with MM and systemic AL amyloidosis.
- ECOG performance status ≥2.
- Patients with uncontrolled hypertension.
- Patients with an active bacterial, viral, or fungal infection.
- Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent \>5 years previously will be allowed. Cancer treated with curative intent \<5 years previously will not be allowed unless approved by the medical monitor.
- Female patients who are pregnant (positive ß-HCG) or breastfeeding.
- Female patients of childbearing potential who are unwilling to use adequate contraceptive techniques during and for 1 month following study treatment with Melphalan HCl for Injection (Propylene Glycol-Free).
- Patients seropositive for HIV.
- Patients who are unwilling to provide informed consent.
- Patients receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 21 days prior to the ASCT, or planning to receive any of these treatments prior to study discharge.
- Patients concurrently participating in any other clinical study.
- Patients who are hypersensitive or intolerant to any component of the study drug formulation.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00925782
Start Date
January 1 2010
End Date
July 1 2011
Last Update
December 17 2019
Active Locations (1)
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1
University of Kansas Medical Center/University of Kansas Cancer Center and Medical Pavillion
Kansas City, Kansas, United States, 66160