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Tailored therapy could boost outcomes in elderly myeloma patients

NCT ID NCT06099912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 personalized treatment plan for people aged 65 and older with newly diagnosed multiple myeloma. The treatment is adjusted based on each patient's frailty level to improve effectiveness and reduce side effects. About 131 participants will receive a combination of drugs including daratumumab, and researchers will track how well the cancer responds and how many patients stop treatment due to intolerance.

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 131 people

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

Started

Sep 2021

Expected to finish

Sep 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.

Who is studied

Diagnosed with primary multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria,aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant.

Ages

65 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: * Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant; * Subject must have documented multiple myeloma as defined by the criteria below: Monoclonal plasma cells in the bone marrow 10% or presence of a biopsy-proven plasmacytoma; Measurable disease as defined by any of the following: * Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or * IgA multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or * Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio. * Has not had prior systemic therapy for multiple myeloma; * The functional reserve of the organs can withstand systemic therapy; * Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF. Exclusion Criteria: * There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment; * Severe organ dysfunction (New York Heart Association class III and IV or transaminases ≥5 normal level, except those caused by cardiac and hepatic amyloidosis secondary to MM) * Patients with prior history of hematologic or solid tumors treated with radiotherapy or chemotherapy(except ≥5 years); * Patients who currently have hematologic tumors or solid tumors that require radiotherapy or chemotherapy; * Non-signation of informed consent.

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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

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

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