Multiple Myeloma Clinical Trial
Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors
Summary
This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.
Full Description
This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors. This study will be conducted in two parts:
Dose Escalation - This part will evaluate increasing doses of VP301 to identify the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). The first patient enrolled on the study will receive the lowest dose of VP301. Once this dose is shown to be safe, an additional patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD or RP2D is reached.
Dose Expansion - Patients with relapsed myeloma and lymphoma will be enrolled and treated with VP301 at the MTD or RP2D.
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of a refractory solid tumor, refractory myeloma or lymphoma with measurable or evaluable disease
Patients must have progressed following all therapies of known, potential clinical benefit, or for whom treatments of known clinical benefit are contraindicated.
Adequate kidney, liver, and hematologic function
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclusion Criteria:
Active brain metastases and history of leptomeningeal metastases.
Myeloma patients with plasmacytoma as only measurable disease
Non-secretory myeloma
Patients with advanced metastatic, symptomatic, visceral spread who are at risk of life-threatening complications
Active or chronic, uncontrolled bacterial, viral, or fungal infection(s)
Abnormal ECG
Has clinically significant cardiovascular disease
Additional active malignancy that may confound the assessment of the study endpoints
Pregnancy or lactation
Known seropositivity for HIV (human immunodeficiency virus) or active hepatitis B or hepatitis C
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