Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003

28. května 2026 aktualizováno: Innovent Biologics (Suzhou) Co. Ltd.

A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of IBI3003 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 255 participants, who will be randomly assigned to the experimental group and the control group in a 2:1 ratio. Approximately 170 participants in the experimental group will receive IBI3003 treatment, while about 85 participants in the control group will receive the investigator's choice of treatment (DPd or PVd). Participants in the experimental group can discontinue medication for observation after meeting the criteria for stopping treatment. During the discontinuation period, if they meet the re-treatment criteria, following discussion between the investigator and the sponsor, and based on the participant's preference, IBI3003 re-treatment may be given until the criteria for terminating treatment are met.

Typ studie

Intervenční

Zápis (Odhadovaný)

255

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 132101

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria：

  1. Age ≥18 years.
  2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.

  3. 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)
  4. Life expectancy ≥3 months.
  5. 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.
  6. Willing and able to comply with the prohibitions and restrictions specified in this protocol.

Exclusion Criteria：

  1. 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.
  2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  3. 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.
  4. Have history of primary immunodeficiency.
  5. Have history of organ transplantation.
  6. 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
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.
Lék: Pomalidomide Capsules
  1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21;
  2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle;
Ostatní jména:
  • P
Lék: Bortezomib for Injection
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.
Ostatní jména:
  • PROTI
Lék: Daratumumab Injection (Subcutaneous Injection)
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.
Ostatní jména:
  • D
Experimentální: 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.
Lék: IBI3003
According to body weight
Ostatní jména:
  • trispecific antibody

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PFS assessed by independent review committee
Časové okno: up to 24 months 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 response criteria
up to 24 months 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 24 months 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 response criteria
up to 24 months after the last enrolled participant receives the first dose of study drug
Negativity rate of minimal residual disease (MRD)
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
Defined as the proportion of participants achieving MRD-negative status
up to 24 months after the last enrolled participant receives the first dose of study drug
Sustained MRD negativity rate
Časové okno: up to 24 months 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 24 months after the last enrolled participant receives the first dose of study drug
6-month MRD negativity rate.
Časové okno: up to 24 months 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 24 months after the last enrolled participant receives the first dose of study drug
12-month MRD negativity rate
Časové okno: up to 24 months 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 24 months after the last enrolled participant receives the first dose of study drug
Objective response rate
Časové okno: up to 24 months 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 criteria
up to 24 months after the last enrolled participant receives the first dose of study drug
Complete response or better rate
Časové okno: up to 24 months 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 criteria
up to 24 months after the last enrolled participant receives the first dose of study drug
Very good partial response or better rate
Časové okno: up to 24 months 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 criteria
up to 24 months after the last enrolled participant receives the first dose of study drug
Duration of response
Časové okno: up to 24 months 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 response criteria or death due to any cause, whichever occurs first
up to 24 months after the last enrolled participant receives the first dose of study drug
Time to response
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
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
up to 24 months after the last enrolled participant receives the first dose of study drug
Time to best response
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
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
up to 24 months after the last enrolled participant receives the first dose of study drug
Time to next treatment
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
Defined as the time from initiation of study drug treatment to initiation of next-line therapy
up to 24 months after the last enrolled participant receives the first dose of study drug
Overall survival
Časové okno: up to 24 months 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 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
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
up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Treatment-related Adverse Event (TRAE) by Severity
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
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
up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Adverse Event of Special Interest (AESI) by Severity
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
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
up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Serious Adverse Event (SAE)
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
Defined as the percentage of participants with SAE
up to 24 months after the last enrolled participant receives the first dose of study drug
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported
up to 24 months after the last enrolled participant receives the first dose of study drug
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Časové okno: up to 24 months after the last enrolled participant receives the first dose of study drug
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported
up to 24 months after the last enrolled participant receives the first dose of study drug

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Innovent Biologics (Suzhou) Co. Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

5. června 2026

Primární dokončení (Odhadovaný)

31. května 2029

Dokončení studie (Odhadovaný)

31. prosince 2029

Termíny zápisu do studia

První předloženo

21. května 2026

První předloženo, které splnilo kritéria kontroly kvality

28. května 2026

První zveřejněno (Aktuální)

3. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CIBI3003A301

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Pomalidomide Capsules

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Gabon

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit