A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003
A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Haiyan Zhu
- Puhelinnumero: 0512-69566088
- Sähköposti: haiyan.zhu@innoventbio.com
Opiskelupaikat
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 132101
- Rekrytointi
- Zhongshan Hospital Fudan University
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Ottaa yhteyttä:
- Peng Liu
- Puhelinnumero: 021-3115199
- Sähköposti: liu.peng@zs-hospital.sh.cn
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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(For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein)
- Urine M-protein ≥200 mg/24h
- Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (<0.26 or >1.65)
- Life expectancy ≥3 months.
- Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate <1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug.
- Willing and able to comply with the prohibitions and restrictions specified in this protocol.
Exclusion Criteria:
- Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.
- Have history of primary immunodeficiency.
- Have history of organ transplantation.
- Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Kokeellinen: IBI3003
participants will receive IBI3003 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.
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According to body weight
Muut nimet:
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Active Comparator: the investigator's choice regimen (DPd or PVd or SVd)
participants will receive DPd or PVd or SVd 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.
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Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
The SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8,15,22 and 29 ,100 mg/d orally.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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PFS assessed by independent review committee
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 response criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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PFS assessed by investigator
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 response criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Negativity rate of minimal residual disease (MRD)
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the proportion of participants achieving MRD-negative status
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Sustained MRD negativity rate
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year
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up to 24 months after the last enrolled participant receives the first dose of study drug
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6-month MRD negativity rate.
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization
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up to 24 months after the last enrolled participant receives the first dose of study drug
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12-month MRD negativity rate
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Objective response rate
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Complete response or better rate
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Very good partial response or better rate
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Duration of response
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 response criteria or death due to any cause, whichever occurs first
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Time to response
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the time from randomization to the date of the first tumor response assessment of PR or better among participants with a best overall response of PR or better
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Time to best response
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the time from randomization to the date of first documented Best Overall Response (BOR) among participants with a best overall response of PR or better
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Time to next treatment
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the time from initiation of study drug treatment to initiation of next-line therapy
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Overall survival
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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OS is defined as the time from the date of randomization to the date of the participant's death due to any cause
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Treatment-related Adverse Event (TRAE) by Severity
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Adverse Event of Special Interest (AESI) by Severity
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Serious Adverse Event (SAE)
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the percentage of participants with SAE
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Aikaikkuna: up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Patologiset prosessit
- Neoplasmat
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Hematologiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Neoplasmat, plasmasolut
- Hemostaattiset häiriöt
- Paraproteinemiat
- Veren proteiinien häiriöt
- Hemorragiset häiriöt
- Patologiset tilat, merkit ja oireet
- Hemic- ja imusuutteet
- Toistuminen
- Multippeli myelooma
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Terapeuttiset lääkkeet
- Lämpötilahallinnon reitit
- Lääkehoito
- Epäorgaaniset kemikaalit
- Boorihapot
- Hapot, ei -karboksyyliset
- Hapot
- Booriyhdisteet
- Pyratsiinit
- Bortetsomibi
- Injektiot
- pomidomidi
- selinexor
- daratumumabi
- Injektiot, ihonalainen
- Fumigant 93
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- CIBI3003A301
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