Tailored therapy could boost outcomes in elderly myeloma patients
NCT ID NCT06099912
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 131 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Sep 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.
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
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65 years and older
- 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: * 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.
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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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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130021, China
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