A Study in Participants With Relapsed or Refractory Multiple Myeloma for QLS4131
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
状態
状態
条件
条件
介入・治療
介入・治療
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
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究連絡先
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
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・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
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
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
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 血管疾患
- 心血管疾患
- 病理学的プロセス
- 新生物
- 疾患の属性
- 免疫系疾患
- 組織型別の新生物
- 血液疾患
- リンパ増殖性疾患
- 免疫増殖性疾患
- 新生物、形質細胞
- 止血障害
- パラタンパク血症
- 血液タンパク質障害
- 出血性疾患
- 病理学的状態、徴候および症状
- ヘミックおよびリンパ疾患
- 再発
- 多発性骨髄腫
- 有機化学物質
- 複素環化化合物、1リング
- 複素環化化合物
- 治療
- 医薬品局のルート
- 薬物療法
- 多環式化合物
- 無機化学物質
- 妊娠
- 妊娠
- ステロイド
- 融合リング化合物
- ステロイド、フッ素化
- 妊娠症
- ボロン酸
- 酸、非カルボン酸
- 酸
- ホウ素化合物
- ピラジン
- ボルテゾミブ
- デキサメタゾン
- 注射
- ポマリドマイド
- ダラトゥムマブ
- 注射、皮下
その他の研究ID番号
その他の研究ID番号
- QLS4131-301
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。