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Dataset from A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

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NIAID Data Ecosystem2026-05-10 收录
下载链接:
https://doi.org/10.25934/PR00012982
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The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

本研究(分为第1部分与第2部分)旨在评估研究药物埃兰妥单抗(elranatamab)的剂量爬坡方案(以低剂量起始,逐步递增至更高剂量)在既往接受治疗后疾病复发,或对治疗原发难治的多发性骨髓瘤(relapsed/refractory multiple myeloma)受试者中的安全性。本研究同时将考察不同剂量埃兰妥单抗以及不同给药间隔的安全性与有效性。受试者将在研究临床中心接受皮下注射给药的埃兰妥单抗。在初始剂量爬坡阶段结束后,受试者将改为每周接受一次给药,后续注射相关的门诊随访频率可随时间逐步降低。受试者的研究参与时长至少为两年。
创建时间:
2026-04-10
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