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

17 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

333

Contatti e Sedi

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

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

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

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

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

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Droga: 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.
Altri nomi:
  • sarclisa
Droga: 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

Altri nomi:
  • Velcade, PS-341
Droga: 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

Altri nomi:
  • Revimid
Droga: 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

Altri nomi:
  • Decadrone

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
≥CR rate after induction treatment
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
MRD negativity rate
Lasso di tempo: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
≥VGPR rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

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

Sponsor

Shanghai Zhongshan Hospital

Investigatori

  • Investigatore principale: Peng Liu, Fudan University

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)

1 giugno 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 settembre 2030

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B2026-229

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli 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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