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

6. listopadu 2026 aktualizováno: 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).

Přehled studie

Detailní popis

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).

Typ studie

Intervenční

Zápis (Odhadovaný)

300

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: LUGUI QIU, Doctor of Medicine (MD)
  • Telefonní číslo: 022-23608124
  • E-mail: qiulg@ihcams.ac.cn

Studijní záloha kontaktů

  • Jméno: GANG AN, Doctor of Medicine (MD)
  • Telefonní číslo: 13502181109
  • E-mail: angang@ihcams.ac.cn

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PFS assessed by independent review committee
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PFS assessed by investigator
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. prosince 2026

Primární dokončení (Odhadovaný)

14. prosince 2029

Dokončení studie (Odhadovaný)

21. května 2030

Termíny zápisu do studia

První předloženo

6. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

6. listopadu 2026

První zveřejněno (Aktuální)

12. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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