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New drug cocktail aims to beat tough myeloma

NCT ID NCT07334535

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 117 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Junling Zhuang

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.