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Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients (CHAMPION-01)

17 juin 2026 mis à jour par: Peng Liu, Shanghai Zhongshan Hospital

A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients

Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China.

And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients

Participants will:

Receive Isatuximab 10 mg/kg iv

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m²
  • Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day
  • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Receive Dexamethasone oral 20 mg
  • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.

During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.

During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a single-arm, multicenter, prospective observational cohort study with a planned total enrollment of 333 transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients aged ≥18 years old in China. All enrolled participants will receive the Isa-VRd induction regimen for 8 cycles (4 weeks per cycle, total 32 weeks). After induction therapy, investigators will determine whether patients continue maintenance treatment based on individual response status, followed by a 2-year long-term follow-up period from the initiation of Isa-VRd treatment, with the maximum observation window of each subject capped at 24 months.

For efficacy evaluation, minimal residual disease (MRD) testing with a cutoff of NGF=10-⁵ will be performed at multiple prespecified time points: at month 8 post-induction, and every 6 months throughout the maintenance and follow-up phase (at months 14, 20 and 26). The primary endpoint of this study is ≥CR rate after induction therapy. Secondary efficacy endpoints include stringent complete response (sCR), very good partial response (VGPR), overall response rate (ORR), duration of response (DOR), time to response (TTR), time to next treatment (TNT), progression-free survival (PFS), overall survival (OS), as well as all safety and tolerability outcomes.

Throughout the entire treatment and follow-up period, all treatment-emergent adverse events (TEAEs), grade ≥3 adverse events, serious adverse events (SAEs), and adverse events of special interest (AESIs, including infusion reactions and second primary malignancies) will be continuously collected and recorded to evaluate the real-world safety profile of the Isa-VRd regimen in Chinese TI-NDMM patients. The overall planned study duration spans approximately 24 months from the first subject's enrollment to the completion of the last patient's 24-month follow-up assessment.

Type d'étude

Observationnel

Inscription (Estimé)

333

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine
    • Guangdong
      • Guangzhou, Guangdong, Chine
        • Recrutement
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Shenzhen, Guangdong, Chine
    • Guangxi
      • Naning, Guangxi, Chine, 450000
        • Recrutement
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, Chine
        • Recrutement
        • Harbin Institute of Hematologic Oncology
        • Contact:
    • Henan
    • Hubei
      • Wuhan, Hubei, Chine
        • Recrutement
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, Chine
      • Nantong, Jiangsu, Chine
        • Recrutement
        • Affiliated Hospital of Nantong University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200032
        • Recrutement
        • Fudan University Affiliated Zhongshan Hospital
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, Chine
    • Sichuan
    • Yunnan
      • Kunming, Yunnan, Chine
        • Recrutement
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients (≥18 years old) with newly diagnosed multiple myeloma, ineligible for autologous stem cell transplantation due to age or comorbidities, who are scheduled to receive the Isatuximab + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd) combination regimen.

La description

Inclusion Criteria:

  • Age ≥18 years
  • Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines

  • Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):

    • Absolute neutrophil count (ANC) ≥1.0×10⁹/L
    • Platelet count ≥50×10⁹/L
    • Calculated creatinine clearance ≥30 mL/min (using Cockcroft-Gault formula)
    • Total bilirubin ≤3× upper limit of normal (ULN)
  • TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)

Exclusion Criteria:

  • Patients currently participating in other interventional clinical studies
  • Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients
  • Severe bacteremia at the time of administration

  • Currently uncontrolled cardiovascular disease, including:

    • Uncontrolled hypertension
    • Uncontrolled arrhythmia
    • Uncontrollable congestive heart failure
    • Unstable angina
  • Patients with peripheral neuropathy ≥Grade 2
  • Active infectious disease, known human immunodeficiency virus (HIV) positivity, active hepatitis B or hepatitis C
  • Patients who are currently pregnant
  • Patients who, at the physician's discretion, are unable to tolerate any drug in the combination regimen

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen

Arm Description:

Isatuximab 10 mg/kg Intravenous injection

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg/m²
  • Cycles 1-8: Days 1, 8, and 15 of each cycle Lenalidomide oral 25 mg/day
  • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Dexamethasone oral 20 mg
  • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen
Médicament: Isatuximab

Isatuximab 10 mg/kg Intravenous (IV) infusion

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally.
Autres noms:
  • sarclisa
Médicament: Bortezomib

Bortezomib subcutaneous injection 1.3 mg/m²

• Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

Autres noms:
  • Velcade, PS-341
Médicament: Lenalidomide

Lenalidomide oral 25 mg/day

• Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Following Cycle 8, the investigator may assess and adjust the treatment regimen

Autres noms:
  • Revlimid
Médicament: Dexamethasone

Dexamethasone oral 20 mg

• Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

Autres noms:
  • Décadron

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
≥CR rate after induction treatment
Délai: After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)
The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.
After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
MRD negativity rate
Délai: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
≥VGPR rate
Délai: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
Overall response rate
Délai: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
Duration of Response
Délai: From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Time to Response
Délai: Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Duration of Treatment
Délai: Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Progression free survival
Délai: Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Overall Survival
Délai: Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Incidence Adverse Events
Délai: From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.
Adverse events (AEs) include treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs), defined as infusion reactions (IRs) and occurrence of second primary malignancies.
From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai Zhongshan Hospital

Les enquêteurs

  • Chercheur principal: Peng Liu, Fudan University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 septembre 2030

Dates d'inscription aux études

Première soumission

5 juin 2026

Première soumission répondant aux critères de contrôle qualité

17 juin 2026

Première publication (Réel)

23 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • B2026-229

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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