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

6 novembre 2026 mis à jour par: 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).

Aperçu de l'étude

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Estimé)

300

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: LUGUI QIU, Doctor of Medicine (MD)
  • Numéro de téléphone: 022-23608124
  • E-mail: qiulg@ihcams.ac.cn

Sauvegarde des contacts de l'étude

  • Nom: GANG AN, Doctor of Medicine (MD)
  • Numéro de téléphone: 13502181109
  • E-mail: angang@ihcams.ac.cn

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PFS assessed by independent review committee
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PFS assessed by investigator
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 décembre 2026

Achèvement primaire (Estimé)

14 décembre 2029

Achèvement de l'étude (Estimé)

21 mai 2030

Dates d'inscription aux études

Première soumission

6 novembre 2026

Première soumission répondant aux critères de contrôle qualité

6 novembre 2026

Première publication (Réel)

12 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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