AzTrials
AzTrials

Multiple MyelomaDynaFiTNCT06099912

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

An observational study of Multiple Myeloma and Frailty, run by FengYan Jin at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma, Frailty
How many people
131 participants
Where
1 siteChina
Study dates
8 Sep 2021to 8 Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 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.

Who may be able to join

  • 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
Show all 10Show fewer
  • 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 join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Fengyan Jin, Professor, +8613844989638, fengyanjin@jlu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With Newly Diagnosed Multiple Myeloma: a Prospective and Multi-center Study

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.

Read the detailed description

Older patients with MM represent a heterogeneous population with different fitness/frailty statuses. Unlike fit patients who can benefit from intensive therapies due to their endurance, frail patients are often susceptible to treatment-related toxicity, leading to treatment discontinuation and poor outcomes. More importantly, frailty can diminish the prognostic impact of disease-related factors over disease trajectory. Thus, it is of utmost importance to determine the fitness/frailty status for treatment decision-making that carefully balances efficacy and safety in this vulnerable population. However, geriatric assessment is often conducted at diagnosis in clinical practice. Although baseline frailty status, as a static risk factor, is significantly associated with OS, its predictive ability decreases over time. Of note, emerging evidence indicates that the fitness/frailty status is highly dynamic because of age increase, disease trajectory, and treatment, raising the notion that frailty-tailored therapy should be designed based on the baseline fitness/frailty status and also according to its longitudinal changes during the treatment course. Thus, current frailty status better predicts OS.

To improve outcomes in elderly patients, this study was designed to investigate an entirely novel therapeutic strategy, the dynamic frailty-tailored therapy, in elderly MM patients with different fitness/frailty statuses.

Keywords
Newly diagnosed multiple myeloma, Frailty, Elderly, Dynamic frailty-tailored therapy
Medical subject headings
Multiple Myeloma, Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (at least PR) on induction therapy

    Overall response rate(ORR) is defined as the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.

    Measured: From the date of inclusion to the end of induction therapy, up to 8 months.

Secondary outcomes (5)

  1. Rate of treatment discontinued(TD)

    The effect of intensive or mild treatment based on dynamic frailty status on treatment discontinued(TD) in elderly newly diagnosed multiple myeloma.

    Measured: The time from the date of inclusion to the date of treatment discontinued from any cause, up to 24 months.

  2. Treatment related adverse event(TRAE)

    Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.

    Measured: Baseline, end of every induction cycle and maintenance cycle, until disease progression or treatment discontinued, up to 24 months.

  3. Early mortality(EM)

    Early mortality is defined as death within 3, 6, 12 and 24 months (EM3,EM6,EM12 and EM24).

    Measured: The time from the date of inclusion to the date of death from any cause, up to 24 months.

  4. Progression-free survival(PFS)

    Progression-free survival(PFS) is defined as the time from inclusion to the time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma.

    Measured: The time from the date of inclusion to the date of first documented evidence of disease progression or death from any cause, up to 24 months.

  5. Overall survival (OS)

    In each case it is the time from inclusion to the time of death from any cause. Individuals who are lost to follow-up or still alive at the time of analysis will be censored at their last known date to be alive.

    Measured: The time from the date of inclusion to the date of death from any cause, up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start8 Sep 2021
  3. Primary completion8 Sep 2026 (estimated)
  4. Study completion8 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
131 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099912
Sponsor's protocol ID
DynaFiT
Acronym
DynaFiT
Status last verified
Jan 2026
First submitted
16 Oct 2023
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kumar SK, Rajkumar V, Kyle RA, van Duin M, Sonneveld P, Mateos MV, Gay F, Anderson KC. Multiple myeloma. Nat Rev Dis Primers. 2017 Jul 20;3:17046. doi: 10.1038/nrdp.2017.46.

    PubMed 28726797

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Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma and Frailty, run by FengYan Jin at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (at least PR) on induction therapy (time frame: From the date of inclusion to the end of induction therapy, up to 8 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06099912, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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