- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: LUGUI QIU, Doctor of Medicine (MD)
- Telefonnummer: 022-23608124
- E-mail: qiulg@ihcams.ac.cn
Undersøgelse Kontakt Backup
- Navn: GANG AN, Doctor of Medicine (MD)
- Telefonnummer: 13502181109
- E-mail: angang@ihcams.ac.cn
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS assessed by independent review committee
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS assessed by investigator
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Neoplasmer
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Tilbagevenden
- Myelomatose
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Terapeutik
- Lægemiddeladministrationsruter
- Lægemiddelterapi
- Polycykliske forbindelser
- Uorganiske kemikalier
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Boronsyrer
- Syrer, ikke -carboxylisk
- Syrer
- Borforbindelser
- Pyraziner
- Bortezomib
- Dexamethason
- Injektioner
- Pomalidomid
- Daratumumab
- Injektioner, subkutan
Andre undersøgelses-id-numre
- QLS4131-301
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .