- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07933432
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).
Přehled studie
Postavení
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
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
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
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
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
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 |
|---|---|
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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 |
|---|---|---|
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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
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Patologické procesy
- Novotvary
- Atributy nemoci
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Hematologická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Novotvary, plazmatické buňky
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Hemoragické poruchy
- Patologické stavy, příznaky a symptomy
- Hemická a lymfatická onemocnění
- Opakování
- Mnohočetný myelom
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Terapeutika
- Trasy pro správu léčiva
- Léčba
- Polycyklické sloučeniny
- Anorganické chemikálie
- Těhotenství
- Těhotenství
- Steroidy
- Sloučeniny roztaveného kruhu
- Steroidy, fluorované
- Těhotenství
- Kyseliny boronové
- Kyseliny, nekarboxylové
- Kyseliny
- Boronové sloučeniny
- Pyraziny
- Bortezomib
- Dexamethason
- Injekce
- Pomalidomid
- daratumumab
- Injekce, subkutánní
Další identifikační čísla studie
- QLS4131-301
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