Pharmacokinetic Study of Propylene Glycol-Free Melphalan HCl for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Melphalan HCl for injection (propylene glycol free)
Intervention description: During the study period, patients will receive 200 mg/m^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.
Intervention MeSH terms: Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; Melphalan HCl; Autologous Transplantation

Summary:

      This study is a single-center, open-label study of high-dose Melphalan HCl (hydrochloric
      acid) for injection (propylene glycol-free Melphalan) conducted in 24 patients, who have
      symptomatic multiple myeloma and qualify for autologous stem-cell transplantation (ASCT).

      There will be three distinct evaluation periods in this trial: a pretreatment period, a study
      period and a follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic multiple myeloma (MM) requiring treatment at or following
             diagnosis.

          -  Patients with MM, who qualify for ASCT therapy, and have received pretransplant
             therapy prior to transplantation.

          -  Adult patients (≥18 years of age) meeting local institutional criteria to receive a
             total Melphalan dose of 200 mg/m^2 as a conditioning regimen.

          -  Patients with an adequate autologous graft, which is defined as an unmanipulated,
             cryopreserved, peripheral blood cell graft containing at least 2 × 106 CD34+ cells/kg,
             based on patient weight.

          -  Patients with adequate organ function, as measured by:

          -  Cardiac: Left ventricular ejection fraction at rest >40% (documented within 30 days
             prior to Day -3).

          -  Hepatic: Bilirubin <2 × the upper limit of normal (ULN) and Alanine
             transaminase/Aspartate transaminase (ALT/AST) <3 × ULN.

          -  Renal: Creatinine clearance >40 mL/min (measured or calculated/estimated).

          -  Pulmonary: Adjusted Diffusing capacity of the lungs for carbon monoxide (DLCO), forced
             expiratory volume in one second (FEV1), forced vital capacity (FVC) >50% of predicted
             value (corrected for hemoglobin level [Hgb]) and documented within prior to day -3.

        Exclusion Criteria:

          -  Patients with systemic AL amyloidosis (immunoglobulin light chain amyloidosis).

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

          -  Patients with uncontrolled hypertension.

          -  Patients with a serious 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 human chorionic gonadotropin [ß-HCG]) or
             breastfeeding.

          -  Female patients of childbearing potential, who are unwilling to use adequate
             contraceptive techniques during and for one 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
             30 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.