Spots Global Cancer Trial Database for A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

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Trial Identification

Brief Title: A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

Official Title: A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma

Study ID: NCT03710915

Conditions

Multiple Myeloma

Relapsed and Refractory Multiple Myeloma

Interventions

HG146

Study Description

Brief Summary: This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.

Detailed Description: This study is mainly designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma. Secondly, to get pharmacokinetic data and preliminary efficacy of HG146 capsule in human. This study adopts the traditional design of "3 + 3" dose escalation. The starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. For each dosing group, subjects are administered orally HG146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. Patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.