Immune Fitness in Older Patients With Relapsed and Refractory Multiple Myeloma (PRIME)

June 24, 2026 updated by: Jules Bordet Institute

Prediction of Response Related to IMmune Age T Cell Fitness in Elderly Patients With Relapsed and Refractory Multiple Myeloma

Relapsed/refractory multiple myeloma (RRMM) predominantly affects older adults, who exhibit marked heterogeneity in treatment outcomes despite receiving the same therapies. Clinical frailty scores, such as the International Myeloma Working Group (IMWG) Frailty Index, predict survival and treatment tolerance but provide limited information on immune competence, a key determinant of response to T-cell-based immunotherapies.

The PRIME study is a prospective, multicenter, non-interventional exploratory study designed to evaluate the relationship between immune fitness and clinical outcomes in patients aged 65 years or older with RRMM treated with standard-of-care chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies. Peripheral blood samples collected before treatment initiation will be analyzed to characterize T-cell differentiation, activation, senescence, exhaustion, and T-helper cell subsets using multiparametric immunophenotyping. Serum biomarkers, including soluble B-cell maturation antigen (sBCMA) and senescence-associated soluble markers, will also be assessed.

  • The primary objective is to determine whether baseline immune profiles are associated with quality of response at 3 months after treatment initiation.
  • Secondary objectives include evaluating the association between immune profiles and treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), other neurological toxicities, and infectious complications. Exploratory analyses will integrate immune, geriatric, sarcopenia, and clinical variables using statistical approaches to identify novel predictors of efficacy, survival, and toxicity.

By combining immune phenotyping with frailty assessment, the PRIME study aims to improve biological risk stratification and support the development of more personalized treatment strategies for older patients with multiple myeloma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The PRIME study is a prospective, multicenter, non-interventional exploratory study investigating immune fitness in patients aged 65 years or older with relapsed or refractory multiple myeloma treated with standard-of-care CAR-T cell therapy or bispecific antibodies.

The study is based on the hypothesis that chronological age and clinical frailty do not fully explain the variability in efficacy and toxicity observed with T-cell-directed immunotherapies. Baseline peripheral blood samples will be collected before treatment initiation for comprehensive immune profiling using multiparametric flow cytometry. The analysis will characterize T-cell differentiation, activation, senescence, exhaustion, regulatory T cells, and T-helper cell subsets through the evaluation of markers including CD3, CD4, CD8, CD25, CD27, CD28, CD38, CD45, CD45RO, CD57, CD127, KLRG1, PD-1, TIM-3, LAG-3, TIGIT, CCR4, CCR6, and CXCR3. Serum samples will also be collected to measure soluble B-cell maturation antigen (sBCMA) and senescence-associated soluble biomarkers.

Participants will be followed according to routine clinical practice. Clinical data collected during follow-up will include disease characteristics, geriatric assessment, sarcopenia assessment, treatment response, and treatment-related toxicities. The primary objective is to evaluate the association between baseline immune fitness and treatment response at 3 months. Secondary analyses will investigate the relationship between immune profiles and adverse events, geriatric status, and sarcopenia. The results are expected to improve understanding of the biological determinants of response and toxicity to T-cell-directed immunotherapies and to support improved risk stratification in older patients with relapsed or refractory multiple myeloma.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
      • Brussels, Brussels Capital, Belgium, 1000
      • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 65 years old
  • Relapsed/refractory multiple myeloma
  • Eligible for a CAR-T cell or bispecific antibody therapies

Exclusion Criteria:

  • <65 years old
  • Active cancer other than myeloma
  • Active AL amyloidosis
  • Central nervous system (CNS) involvement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Overall
Immunophenotyping arm
Other: immunophenotyping of lymphocyte

Multiparametric flow cytometry will be used to characterize peripheral T-cell compartment, including differentiation status, senescence-associated phenotypes and exhaustion markers, as well as Th1/Th17 and Treg.

The following markers will be used : CD57, CD25, CD3, CD45RO, CD38, CD27, CD8, CD4, CD45, KLRG1, CD127, CD28, TIGIT, CCR4, LAG-3, CD3, CCR6, CD8, CD4, CD45, PD-1, CXCR3, TIM-3. A serum sample will be collected to measure sBCMA and senescence-associated soluble markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ≥VGPR or better according to IMWG criteria at 3 months.
Time Frame: 3 months after the treatment
The association of VGPR and immune profile will be assessed.
3 months after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB20260367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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