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

28 maggio 2026 aggiornato da: 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)

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

255

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 132101

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Droga: 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;
Altri nomi:
  • P
Droga: 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.
Altri nomi:
  • V
Droga: 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.
Altri nomi:
  • D
Sperimentale: 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.
Droga: IBI3003
According to body weight
Altri nomi:
  • trispecific antibody

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS assessed by independent review committee
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS assessed by investigator
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 giugno 2026

Completamento primario (Stimato)

31 maggio 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIBI3003A301

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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