Phase 1/2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT00461045 (View complete trial on
DFCI Protocol ID: 06-064


This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells. Amendment 11 to the protocol is currently recruiting to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression during or within 60 days of such therapy.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Paul Richardson, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Deborah Doss, 617-632-5672,

Eligibility Criteria

Inclusion Criteria: - Age >=18 years - Karnofsky Performance Status (KPS) >=70% - Histologic evidence of multiple myeloma, relapsed or relapsed/refractory disease for which no other approved treatment is available and clinically indicated - Adverse Events resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to acceptable grades - Adequate bone marrow, renal, adrenal, pancreatic and liver function - Hemoglobin >= 8 g/dL - Absolute neutrophil count >= 1.5 x 10^9 /L - Platelet count >= 75 x 10^9 /L (without transfusions) - Signed informed consent Exclusion Criteria: - Administration of chemotherapy, radiation, biological, immunotherapy or investigational agent within 28 days (6 weeks for nitrosourea and 12 weeks for BMT) - Patients may be receiving steroids or bisphosphonates, but doses must be stable - Patients must be off intrathecal therapy for at least 3 months prior to dosing - Ongoing coagulopathies and/or taking anticoagulants - Patients with evidence of mucosal or internal bleeding and/or platelet refractory - Significant cardiac disease - Patients with a prior hypersensitivity reaction of CTCAE Grade >= 3 to therapy containing propylene glycol or ethanol. - Pregnant or breast-feeding women - Significant bacterial, viral or fungal infection - Any other medical conditions that would impose excessive risk to the patient
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