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Four-Drug cocktail aims to control myeloma without transplant

NCT ID NCT07663253

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a combination of four drugs—isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd)—in people newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. The goal is to see how well the regimen controls the disease and what side effects occur in real-world practice. Participants receive the drugs in cycles over about eight months, followed by possible maintenance therapy. The study will measure response rates, including how deeply the cancer is suppressed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab (Sarclisa) combined with bortezomib, lenalidomide, and dexamethasone
What this could lead to
If successful, this combination could offer a powerful, chemotherapy-free option to control multiple myeloma in people who cannot undergo a stem cell transplant.
What could go wrong
This is an observational study without a comparison group, so results may be less definitive. Side effects from the drug combination can be serious, including infections and blood count changes.

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.

Participants

About 333 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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.

Who is studied

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.

Ages

18 years and older

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: * 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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. 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

  • Affiliated Hospital of Nantong University

    RECRUITING

    Nantong, Jiangsu, China

  • Fudan University Affiliated Zhongshan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Harbin Institute of Hematologic Oncology

    RECRUITING

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Jiangsu Provincial People's Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Naning, Guangxi, 450000, China

  • The First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, China

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

    RECRUITING

    Wuhan, Hubei, China

  • Xijing Hospital, Air Force Medical University

    RECRUITING

    Xi’an, Shanxi, China

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