Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Status: Recruiting
Phase: Phase 1
Diagnosis: Multiple Myeloma
NCT ID: NCT00461045
(View complete trial on ClinicalTrials.gov)
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Paul Richardson, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
ddoss@partners.org
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