Health TrialsbyHealthPanel

Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines

Absolute neutrophil count (ANC) ≥1.0×10⁹/L

Platelet count ≥50×10⁹/L

Disqualifiers

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

Uncontrolled hypertension

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Isatuximab

    Drug

    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.

  • Bortezomib

    Drug

    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

  • Lenalidomide

    Drug

    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

  • Dexamethasone

    Drug

    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

Treatment groups

333 Participants
are divided into 1 treatment group
Group A: Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen4 interventions

Trial outcomes

Primary outcomes

1

≥CR rate after induction treatment

The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.

Time frame
After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)

Secondary outcomes

1

MRD negativity rate

Time frame
At the end of induction phase (Week 32 / approximately 8 months)
2

≥VGPR rate

Time frame
At the end of induction phase (Week 32 / approximately 8 months)
3

Overall response rate

Time frame
At the end of induction phase (Week 32 / approximately 8 months)
4

Duration of Response

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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