Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01416428
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-008
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Irene Ghobrial, MD,
Dana-Farber Cancer Institute
Noopur Raje, MD,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Stacey Chuma, 617-632-4863,
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- Histologically confirmed diagnosis of a hematologic malignancy, excluding patients
with acute leukemia or MDS.
- Relapsed after standard therapy for their malignancy and considered to be an
appropriate candidate for a Phase 1 clinical study by their treating physician.
- Multiple myeloma with measurable disease
- Waldenström macroglobulinemia with symptomatic relapse
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Patients must sign a written informed consent form in accordance with federal, local,
and institutional guidelines.
- Female patients of childbearing potential must have a negative serum or urine
pregnancy test and agree to use effective contraception. Male patients must use an
effective barrier method of contraception.
- Chemotherapy with approved or investigational anticancer therapeutics, including
steroid therapy intended to treat underlying malignancy, within 3 weeks prior to
first dose or 6 weeks for antibody therapy.
- Radiation therapy within 3 weeks prior to first dose. Radioimmunotherapy within 8
weeks prior to first dose. Localized radiation therapy within 1 week prior to first
- Immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where
6 weeks is required).
- Prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks;
allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should
not have evidence of moderate-to-severe graft-vs-host disease (GvHD; as defined in
- Evidence of central nervous system (CNS) lymphoma.
- Prior treatment with carfilzomib.
- Major surgery within 3 weeks prior to first dose.
- Symptomatic Congestive heart failure, ischemia, conduction abnormalities, or
myocardial infarction within 6 months.
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals.
- Known or suspected human immunodeficiency virus (HIV) infection or patients who are
- Active hepatitis A, B, or C infection.
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the
- Patients with pleural effusions requiring routine thoracentesis or ascites requiring
- Female patients who are pregnant or lactating.