In multiple myeloma, a high-dose conditioning treatment prior to stem cell transplant
Prescribing Information Important Safety Information

    EVOMELA Efficacy & Safety

    EVOMELA—Efficacy and safety demonstrated in a pivotal clinical study1-3

    EVOMELA was evaluated for myeloablative conditioning in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT) in a Phase IIb, multicenter, open-label, single-arm, nonrandomized US clinical study (n=61).1,3

    Please see pivotal study design here.

    Study confirmed the efficacy and acceptable safety profile of EVOMELA as a high-dose conditioning regimen for ASCT in patients with multiple myeloma.1,3

    Contraindicated in patients with a history of serious allergic reaction to melphalan. Please see the safety profile of EVOMELA.1

    Proven efficacy

    • An overall response rate of 95% at follow-up (Day +90 to Day +100)1

    *Overall response rate is categorized as partial response or better.1 † Follow-up = Day +90 to Day +100.1

    Myeloablation and engraftment achieved in all patients1

    ‡Median time to myeloablation or engraftment.1 §Myeloablation was defined as any of the following: absolute neutrophil count (ANC) <500/ mm,3 absolute lymphocyte count <100/mm,3 or platelet count <20,000/mm.3 Neutrophil engraftment was defined as ANC>500/mm3 x 3 consecutive daily assessments. Platelet engraftment was defined as untransfused platelet counts >20,000/mm3 x 3 consecutive daily assessments. Nonengraftment was defined as failure to reach an ANC>500/mm3 x 3 consecutive daily assessments by Day 90–100.1

    Selected Important Safety Information

    Warnings and Precautions

    Gastrointestinal Toxicity:
    • For patients receiving EVOMELA as part of a conditioning regimen, nausea, vomiting, mucositis, and diarrhea may occur in over 50% of patients. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. The frequency of grade 3/4 mucositis in clinical studies was 13%. Provide nutritional support and analgesics for patients with severe mucositis.
    References
    1. EVOMELA Prescribing Information. Acrotech Biopharma, LLC. 
    2. Aljitawi OS, Ganguly S, Abhyankar SH, et al. Phase IIa cross-over study of propylene glycol–free melphalan (LGD-353) and alkeran in multiple myeloma autologous transplantation. Bone Marrow Transplant. 2014;49(8):1042-1045.
    3. Hari P, Aljitawi OS, Arce-Lara C, et al. A phase IIb, multicenter, open-label, safety, and efficacy study of high-dose, propylene glycol–free melphalan hydrochloride for injection (EVOMELA) for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation. Biol Blood Marrow Transplant. 2015;21(12):2100-2105.
    Important Safety Information
    Click to Hide Advanced Floating Content
    Important Safety Information
    Warnings and Precautions

    Bone Marrow Suppression: For patients receiving EVOMELA as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.

    See More