Multiple Myeloma Clinical Trial
Official title:
AA Phase IIA Open-Label, Randomized, PK Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in MM Patients Undergoing Autologous Transplantation
NCT number | NCT00925782 |
Other study ID # | CDX-353-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | July 2011 |
Verified date | December 2019 |
Source | Acrotech Biopharma LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 transplant (ASCT).
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center/University of Kansas Cancer Center and Medical Pavillion | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
Acrotech Biopharma LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve (0-t) | AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2. |
Day -3 and Day -2 | |
Primary | Concentration-Max (Cmax) | Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations. The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2. |
Day -3 and Day -2 | |
Secondary | Determination of Myeloablation Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT | ANC <0.5 × 109/L, absolute lymphocyte count (ALC) <0.1 × 109/L, platelet count <20,000/mm3, or bleeding requiring transfusion. The first of 2 consecutive days for which cell counts drop below these cutoff levels was recorded as the date of myeloablation. Since the two treatments were administered consecutively with 1 day rest, the time to myeloablation and myeloablation rate was measured after both treatments were administered. Comparison of sequence effect was not planned in the study and due to small sample size, it was not performed. |
30 days | |
Secondary | Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT | Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed. Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered. |
30 days |
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