- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: LUGUI QIU, Doctor of Medicine (MD)
- Telefonnummer: 022-23608124
- E-post: qiulg@ihcams.ac.cn
Studera Kontakt Backup
- Namn: GANG AN, Doctor of Medicine (MD)
- Telefonnummer: 13502181109
- E-post: angang@ihcams.ac.cn
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PFS assessed by independent review committee
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PFS assessed by investigator
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Patologiska processer
- Neoplasmer
- Sjukdomsegenskaper
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Neoplasmer, Plasmacell
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Hemorragiska störningar
- Patologiska tillstånd, tecken och symtom
- Hemiska och lymfsjukdomar
- Upprepning
- Multipelt myelom
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Terapeutik
- Drogadministrationsvägar
- Narkotikabehandling
- Polycykliska föreningar
- Oorganiska kemikalier
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Steroider, fluorerade
- Graviditet
- Borrsyror
- Syror, icke -karboxyl
- Syror
- Boreföreningar
- Pyraziner
- Bortezomib
- Dexametason
- Injektion
- pomalidomid
- daratumumab
- Injektioner, subkutan
Andra studie-ID-nummer
- QLS4131-301
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