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Frailty-guided treatment plans for older adults with newly diagnosed multiple myeloma

Studies whether treatment tailored to changing frailty helps adults 65 and older with myeloma.

Key facts

Who runs it
FengYan Jin
Where
Changchun, ChinaSee the site
Trial code
Registry title
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM
Status
Recruiting
People taking part
131 people, planned
Started
8 Sept 2021
Expected to end
8 Sept 2029
Type of study
Observational
Record updated
12 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 65 or older with newly diagnosed multiple myeloma who cannot have, or do not plan to have right away, a stem-cell transplant and have not yet had treatment for myeloma.

Age
65 years or older
Sex
Men and women
Disease stage
Newly diagnosed multiple myeloma with measurable disease (M-protein or free light chain levels as set in the record), or a biopsy-proven plasmacytoma. Monoclonal plasma cells in the bone marrow 10%.
Earlier treatment
No earlier systemic treatment for multiple myeloma. Not able to have a transplant, or no plan for an immediate transplant.
Biomarker or test result
Serum M-protein ≥1.0 g/dL or urine M-protein ≥200 mg/24 hours. For IgA myeloma, serum M-protein ≥0.5 g/dL. For light chain myeloma, serum free light chain ≥10 mg/dL with an abnormal kappa/lambda ratio.

Main reasons for not taking part

  • Active infection that needs treatment
  • Severe organ problems (heart failure class III or IV, or liver enzymes ≥5 times normal, with an exception for amyloidosis caused by myeloma)
  • Past blood cancer or solid tumor treated with radiotherapy or chemotherapy, unless it was 5 years ago or more
  • Current blood cancer or solid tumor that needs radiotherapy or chemotherapy
  • Not signing the informed consent form

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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)
  • Non-signation of informed consent

Where in China

  • The First Hospital of Jilin UniversityChangchun, ChinaContact: Fengyan Jin, ProfessorTaking people

About the trial

What the trial wants to find out

Frailty is dynamic and confers poor outcomes in elderly patients with newly diagnosed multiple myeloma (NDMM), mainly because of the high prevalence of treatment discontinuation due to intolerability. We designed a multi-center prospective study (DynaFiT) based on our real-life practice to evaluate the feasibility and benefits of a dynamic frailty-tailored therapy in elderly patients with different fitness/frailty statuses.

Read full original descriptionShow less

Since Dara-based treatment have recently become the new standard regimens, in this amendment of the study, daratumumab added to VRd is recommended as induction therapy regimen.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With Newly Diagnosed Multiple Myeloma: a Prospective and Multi-center Study
Plain-language title
Frailty-guided treatment plans for older adults with newly diagnosed multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 February 2026