New drug cocktail aims to beat tough myeloma
NCT ID NCT07334535
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a four-drug regimen (isatuximab plus standard VRD) against the standard three-drug VRD in 117 newly diagnosed multiple myeloma patients who are not eligible for transplant and have high-risk features. The goal is to see if adding isatuximab leads to more patients achieving undetectable cancer levels (MRD negativity) at 12 months. Participants will receive treatment for up to 12 cycles followed by maintenance therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Isatuximab (a targeted antibody) combined with bortezomib, lenalidomide, and dexamethasone (standard chemotherapy drugs)
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for high-risk multiple myeloma, potentially leading to deeper remissions and longer survival.
- What could go wrong
- This is a relatively small phase 4 trial (117 participants) and has not yet started recruiting. The added drug may increase side effects without guaranteeing better outcomes, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 117 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Newly diagnosed Multiple myeloma ,meeting the IMWG 2025 definition of high-risk MM (any one criterion): (1) Del(17p) (\>20% of plasma cells) and/orTP53 mutation or(2)One of these translocations cooccurring with 1q+ and/or del(1p32) , or t(4;14), or t(14;16), or t(14;20) or (3) Monoallelic del(1p32) along with 1q+ or biallelic del(1p32) or(4) High β2M (\>5.5 mg/dL) with normal creatinine (\<1.2 mg/dL) or(5)Or presents with any other high-risk feature: meeting diagnostic criteria for primary plasma cell leukemia or presence of extramedullary plasmacytoma at baseline; * Age ≥18 years and ≤80 years; * Not eligible for autologous hematopoietic stem cell transplantation or has declined transplantation for other reasons. * ECOG score 0-2 * Expected survival time \> 3 months * Sufficient organ function is defined as follows: absolute neutrophil count ≥ 1.0×10\^9/L, platelet count ≥ 50×10\^9/L (when the proportion of bone marrow plasma cells is \<50%), hemoglobin ≥ 7.5 g/dL; total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal; creatinine clearance rate ≥ 30 mL/min; left ventricular ejection fraction ≥ 50%. * Fertile female or male subjects must agree to take effective contraceptive measures during the study period and within the specified time after the last administration. * Voluntarily participated in this study, signed the informed consent form, had good compliance, and was cooperative during the follow-up. Exclusion Criteria: * Prior systemic anti-myeloma therapy; * Viral infections including HBV, HCV, HIV, etc.; * Serious cardiovascular and cerebrovascular diseases, such as: within 6 months before screening, myocardial infarction, unstable angina pectoris, severe arrhythmia, New York Heart Function Classification III-IV grade, or left ventricular ejection fraction \<50%. * Severe neurological or mental disorders that affect the ability to give informed consent or comply with the protocol. * Had an allergic reaction to isatuximab, bortezomib, lenalidomide, dexamethasone or any excipients * Pregnant or lactating women. * Participated in other interventional clinical studies, or had received other anti-tumor treatments within the specified time before the first administration of this study. * The researcher believes that there are any other circumstances unsuitable for participating in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Junling Zhuang
Beijing, Beijing Municipality, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas