A Phase 2/3 interventional study of Isatuximab and VRD in Multiple Myeloma, sponsored by The Affiliated People's Hospital of Ningbo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 2/3, Interventional, and Prevention
To evaluate the overall response rate, safety, and the 12-cycle clearance rate of circulating plasma cells (CPCs) in patients with newly diagnosed transplant-ineligible multiple myeloma stratified as high-risk based on circulating plasma cell assessment treated with isatuximab combined with reduced-dose VRD regimen
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 15 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →The Affiliated People's Hospital of Ningbo University is the lead sponsor of 10 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnosis of primary plasma cell leukemia, solitary plasmacytoma, smoldering multiple myeloma or secondary multiple myeloma.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Isa-VRdlite for high risk fail MM patinets base on CPSc
Drug: Isatuximab · Drug: VRD
Newly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below: Isatuximab (Isa) 10 mg/kg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy. Reduced-intensity VRD (VRDlite) Bortezomib (V): 1.3 mg/m², subcutaneous injection, Days 1, 8, 15, 22 per cycle. This administration route reduces the incidence of peripheral neuropathy. Lenalidomide (R): 15 mg once daily orally, Days 1-21 per cycle. Dose should be further individualized and reduced for patients with renal insufficiency according to eGFR
Newly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below: Isatuximab (Isa) 10 mg/kg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy. Reduced-intensity VRD (VRDlite) Bortezomib (V): 1.3 mg/m², subcutaneous injection, Days 1, 8, 15, 22 per cycle. This administration route reduces the incidence of peripheral neuropathy. Lenalidomide (R): 15 mg once daily orally, Days 1-21 per cycle. Dose should be further individualized and reduced for patients with renal insufficiency according to eGFR Dexamethasone (D): 20 mg once daily, orally or intravenously
Overall response rate
defined as the proportion of patients achieving stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] or partial response \[PR\]
Time frame: 12months
12-cycle clearance rate of circulating plasma cells (CPCs).
12-cycle clearance rate of circulating plasma cells (CPCs).
Time frame: 12months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Isatuximab
The Affiliated People's Hospital of Ningbo University