Actively Recruiting

Age: 65Years +
All Genders
NCT06099912

Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM

Led by FengYan Jin · Updated on 2026-02-12

131

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

Sponsors

F

FengYan Jin

Lead Sponsor

S

Sun Yat-Sen University Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. 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.

CONDITIONS

Official Title

Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 65 years or older who are either not eligible for transplant or do not plan immediate transplant
  • Diagnosed with multiple myeloma confirmed by 10% or more monoclonal plasma cells in the bone marrow or biopsy-proven plasmacytoma
  • Measurable disease with serum or urine monoclonal protein levels meeting specified thresholds
  • No prior systemic therapy for multiple myeloma
  • Organs must have sufficient function to tolerate systemic therapy
  • Able and willing to provide informed consent and follow study requirements
Not Eligible

You will not qualify if you...

  • Active systemic viral, fungal, or bacterial infections requiring treatment
  • Severe organ dysfunction defined as NYHA class III or IV heart failure or high transaminase levels, except if caused by amyloidosis secondary to multiple myeloma
  • History of hematologic or solid tumors treated with chemotherapy or radiotherapy within the past 5 years
  • Current hematologic or solid tumors requiring chemotherapy or radiotherapy
  • Failure to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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