Isatuximab-VRd for transplant-ineligible newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective observational cohort enrolling up to 333 adults with transplant-ineligible newly diagnosed multiple myeloma in China. All participants receive the Isa-VRd induction regimen (Isatuximab, Bortezomib, Lenalidomide, Dexamethasone) for 8 cycles over about 32 weeks, followed by maintenance decisions and a 2-year follow-up. Primary endpoint is the rate of achieving complete response after induction; secondary endpoints include MRD negativity, response depth (sCR, VGPR, ORR), durability of response, and survival outcomes, along with safety. MRD testing with NGF 10-5 will be performed at predefined time points to correlate depth of response with long-term outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• 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, China Recruiting
• Harbin Institute of Hematologic Oncology
  Harbin, Heilongjiang, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Peng Liu — Fudan University
• Study coordinator: Peng Liu
• Email: liu.peng@zs-hospital.sh.cn
• Phone: +86-021-64041990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone combination for relapsed/refractory multiple myeloma

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• Maintenance treatment for multiple myeloma after stem cell transplant

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• Combination treatment for transplant ineligible patients with Multiple Myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.