PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation

NCT ID: NCT00925782

Last Updated: 2019-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-07-31

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 transplant (ASCT).

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 patients who have symptomatic MM and qualify for ASCT.

During the Study Period, patients will be randomized to receive 100mg/m2 of either Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection on Day -3 and the alternate drug product on Day -2. Blood samples for pharmacokinetic (PK) evaluation will be withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day -2).

Following one day of rest after the myeloablative conditioning (Day -1), patients will receive an autologous graft.

Conditions

Multiple Myeloma

Keywords

autologous stem cell transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Melphalan-Alkeran

Subjects begin with treatment Melphalan and crossover to treatment Alkeran

Group Type: OTHER

Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection

Intervention Type: DRUG

Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.

Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)

Intervention Type: DRUG

Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.

Alkeran-Melphalan

Subjects begin with treatment Alkeran and crossover to treatment Melphalan.

Group Type: OTHER

Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection

Intervention Type: DRUG

Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.

Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)

Intervention Type: DRUG

Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.

Interventions

Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection

Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.

Intervention Type: DRUG

Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)

Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.

Intervention Type: DRUG

Other Intervention Names

Evomela; L-PAM, L-Sarcolysin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acrotech Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omar Aljitawi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center/University of Kansas Cancer Center and Medical Pavillion

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

CDX-353-001

Identifier Type: -

Identifier Source: org_study_id