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A Study in Participants With Relapsed or Refractory Multiple Myeloma for QLS4131

2026年11月6日 更新者:Qilu Pharmaceutical Co., Ltd.

A Phase 3 Randomized Study Comparing QLS4131 Injection Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this clinical trial is to evaluate the efficacy and safety of QLS4131 compared with the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma (RRMM).

調査の概要

詳細な説明

This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of QLS4131 compared to the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma who have previously received 1-4 lines of therapy and have been exposed to three classes of drugs (proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies). The plan is to enroll approximately 300 participants, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Approximately 150 participants in the experimental group will receive QLS4131 treatment, while about 150 participants in the control group will receive the investigator's choice of treatment (DPd or PVd).

研究の種類

介入

入学 (推定)

300

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:LUGUI QIU, Doctor of Medicine (MD)
  • 電話番号:022-23608124
  • メール:qiulg@ihcams.ac.cn

研究連絡先のバックアップ

  • 名前:GANG AN, Doctor of Medicine (MD)
  • 電話番号:13502181109
  • メール:angang@ihcams.ac.cn

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age ≥18 years.
  • Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
  • At least one of the following measurable disease indicators:
  • Serum M-protein ≥ 5 g/L
  • Urine M-protein ≥200 mg/24h
  • Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio.
  • Received 1-4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).
  • Willing and able to comply with the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Prior treatment with both the BCMA-targeted therapy and the GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy alone are eligible.
  • Known hypersensitivity to any of the ingredients of investigational drug.
  • Diagnosis of plasma cell leukemia(peripheral blood plasma cells ≥5%),or primary light chain amyloidosis.
  • Known active central nervous system (CNS) involvement, or clinical signs and symptoms suggestive of meningeal involvement by multiple myeloma.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:QLS4131

Participants will receive QLS4131 injection until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

QLS4131 will be administered subcutaneously.

アクティブコンパレータ:The investigator's choice regimen (DPd or PVd )

Participants will receive DPd or PVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21;The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle.

The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.

The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.

The DPd treatment regimen, one cycle every 28 days: Dexamethasone 20 mg orally, on days 1, 2, 8, 9, 15, 16, 22, and 23 (total 40 mg per week).

The PVd treatment regimen, one cycle every 21 days: Dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, and 12 of cycles 1-8, and on days 1, 2, 8, and 9 from cycle 9 onwards.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
PFS assessed by independent review committee
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug

二次結果の測定

結果測定
メジャーの説明
時間枠
PFS assessed by investigator
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Very good partial response or better rate
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Very good partial response or better rate is defined as the percentage of participants who achieve very good partial response or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Negativity rate of minimal residual disease (MRD)
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Defined as the proportion of participants achieving MRD-negative status.

up to 2 years after the last enrolled participant receives the first dose of study drug
Sustained MRD negativity rate
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year.

up to 2 years after the last enrolled participant receives the first dose of study drug
6-month MRD negativity rate
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization.

up to 2 years after the last enrolled participant receives the first dose of study drug
12-month MRD negativity rate
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization.

up to 2 years after the last enrolled participant receives the first dose of study drug
Objective response rate
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Objective response rate is defined as the percentage of participants who achieve PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Complete response or better rate
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Complete response or better rate is defined as the percentage of participants who achieve CR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Duration of response
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death from any cause.

up to 2 years after the last enrolled participant receives the first dose of study drug
PFS Rate at 6, 12, and 18 Months
時間枠:6, 12, and 18 months after randomization

Percentage of participants who remain alive and progression-free at 6, 12, and 18 months after randomization, as assessed by both the independent review committee (IRC) and the investigator according to IMWG 2016 response criteria.

6, 12, and 18 months after randomization
Overall survival
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

up to 2 years after the last enrolled participant receives the first dose of study drug
OS Rate at 12 and 24 Months
時間枠:12 and 24 months after randomization

Percentage of participants who remain alive at 12 and 24 months after randomization.

12 and 24 months after randomization
Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Number of participants with AEs by Severity will be reported.

up to 2 years after the last enrolled participant receives the first dose of study drug
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
時間枠:up to 2 years after the last enrolled participant receives the first dose of study drug

Change from baseline scores

up to 2 years after the last enrolled participant receives the first dose of study drug

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月30日

一次修了 (推定)

2029年12月14日

研究の完了 (推定)

2030年5月21日

試験登録日

最初に提出

2026年11月6日

QC基準を満たした最初の提出物

2026年11月6日

最初の投稿 (実際)

2026年11月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月6日

最終確認日

2026年11月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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