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再発性/難治性多発性骨髄腫の成人患者を対象としたモダカフスプアルファの研究

基本情報

NCT ID
NCT03215030
ステータス
中止
試験のフェーズ
第1/第2相
試験タイプ
介入
目標被験者数
272
治験依頼者名
Teva Branded Pharmaceutical Products R&D, Inc.

概要

The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

対象疾患

Multiple Myeloma

介入

Modakafusp alfa(DRUG)
Dexamethasone(DRUG)

依頼者(Sponsor)

実施施設 (5)

大垣市民病院

Gifu, Gifu, Japan

京都府立医科大学附属病院

Kyoto, Kyoto, Japan

日本赤十字社医療センター

Tokyo, Japan

独立行政法人国立病院機構岡山医療センター

Okayama, Okayama-ken, Japan

名古屋市立大学病院

Nagoya, Aichi-ken, Japan