Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple myeloma patients (MM) undergoing autologous transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma LLC; Spectrum Pharmaceuticals, Inc
• Collaborators: Beckloff Associates, Inc.; Clinipace LTD; Clinipace Worldwide; Kansas City Bioanalytical Laboratories
• Treatments: Melphalan

Criteria

Inclusion Criteria:

• Patients with symptomatic MM based on IMWG guidelines requiring treatment who are eligible for ASCT.

• Patients who are 70 years of age or younger at time of transplant. Patients older than 70 years of age may be enrolled 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, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 × 106 CD34+ cells/kg based on patient body weight.

Patients with adequate organ function as measured by:

• Cardiac function: Left ventricular ejection fraction at rest >40% (documented within 8 weeks prior to Day -3).

• Hepatic function: Bilirubin <2 × the upper limit of normal and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <3 × upper limit of normal.

• Renal function: Creatinine clearance >40 mL/minute (measured or calculated/estimated).

• Pulmonary function: Carbon monoxide diffusing capacity (DLCO)corrected for hemoglobin (Hgb), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC), and oxygen saturation >92% on room air (documented within 4 weeks prior to Day -3).

• Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

• Patients with smoldering MM not requiring therapy.

• Patients with plasma cell leukemia.

• Patients with systemic amyloid light chain amyloidosis.

• Patients with uncontrolled hypertension.

• Patients with an active bacterial, viral, or fungal infection.

• Patients with a life expectancy of < 6 months.

• 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 or breastfeeding.

• Female patients of childbearing potential who are unwilling to use adequate contraceptive techniques during and for 3 months following study treatment with Melphalan HCl for Injection (Propylene Glycol-Free).

• Patients seropositive for Human Immunodeficiency Virus(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 Day +30.

• Patients concurrently participating in any other clinical study involving ASCT.

• Patients who are hypersensitive or intolerant to any component of the study drug formulation.