Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

torstai 28. toukokuuta 2026 päivittänyt: 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)

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

255

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Kiina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kiina, 132101
        • Zhongshan Hospital Fudan University
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: 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.
Lääke: 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;
Muut nimet:
  • P
Lääke: 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.
Muut nimet:
  • V
Lääke: 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.
Muut nimet:
  • D
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.
Lääke: IBI3003
According to body weight
Muut nimet:
  • trispecific antibody

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
PFS assessed by independent review committee
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
PFS assessed by investigator
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Innovent Biologics (Suzhou) Co. Ltd.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Perjantai 5. kesäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Torstai 31. toukokuuta 2029

Opintojen valmistuminen (Arvioitu)

Maanantai 31. joulukuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 21. toukokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 28. toukokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 3. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 3. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 28. toukokuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CIBI3003A301

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Uusiutunut tai refraktaarinen multippeli myelooma

Kliiniset tutkimukset Pomalidomide Capsules

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Togo

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

Tilaa