PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Intervention: Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection; Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)
Intervention description: 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.; 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 MeSH terms: Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: autologous stem cell transplantation

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).
    

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.