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

NCT07663253 | Recruiting FDA Drug

• 1 other identifier: B2026-229
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

isatuximab; transplant-ineligible newly diagnosed multiple myeloma; TI NDMM; Multiple Myeloma

Outcome Measures

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.

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

Secondary Outcomes (9)

• MRD negativity rate

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

• ≥VGPR rate

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

• Overall response rate

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

• Duration of Response

  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

  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

Study Arms (1)

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

Drug: Isatuximab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

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.

Also known as: sarclisa

Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen

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

Also known as: Velcade, PS-341

Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）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

Also known as: Revlimid

Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）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

Also known as: Decadron

Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (13)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Naning, Guangxi, 450000, China

RECRUITING

Harbin Institute of Hematologic Oncology

Harbin, Heilongjiang, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

Wuhan, Hubei, China

RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Fudan University Affiliated Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Xijing Hospital, Air Force Medical University

Xi’an, Shanxi, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab; Bortezomib; Lenalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Peng Liu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Liu

CONTACT

+86-021-64041990; liu.peng@zs-hospital.sh.cn

Jiadai Xu

CONTACT

xu.jiadai@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hematology department

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)