Myeloma MultiplePRIMENCT07674498
Immune Fitness in Older Patients With Relapsed and Refractory Multiple Myeloma
A study testing immunophenotyping of lymphocyte in people with Myeloma Multiple, run by Jules Bordet Institute at 3 sites in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- immunophenotyping of lymphocyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesBelgium
- Study dates
- 3 Jun 2026to Sep 2027
- Phase
- Interventional
- 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
Who may be able to join
- ≥ 65 years old
- Relapsed/refractory multiple myeloma
- Eligible for a CAR-T cell or bispecific antibody therapies
Who cannot join
- <65 years old
- Active cancer other than myeloma
- Active AL amyloidosis
- Central nervous system (CNS) involvement
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, Brussels Capital, 1070
Marie Vercruyssen, MD, +32497840746, marie.vercruyssen@hubruxelles.be
- Not yet recruiting
CHU Saint-Pierre
Brussels, Brussels Capital, 1000
Nicolas Cilla, MD, +32 2 535 31 11, marie.vercruyssen@hubruxelles.be
- Not yet recruiting
institut roi albert II
Woluwe-Saint-Lambert, Brussels Capital, 1200
Marie-Christiane Vekemans, MD, PHD, +32 2 764 12 00, marie.vercruyssen@hubruxelles.be
About this study
Official title: 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.
Read more
- 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.
Read the 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.
- Conditions
- Myeloma Multiple
- Being tested
- immunophenotyping of lymphocyte
- Keywords
- multiple myeloma, immunosenescence, Exhaustion, T-fitness, T lymphocyte, elderly, T cell therapies
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunophenotyping of lymphocyteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Overall | Other | Immunophenotyping arm Receives: Other: immunophenotyping of lymphocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ≥VGPR or better according to IMWG criteria at 3 months.
The association of VGPR and immune profile will be assessed.
Measured: 3 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start3 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674498
- Sponsor's protocol ID
- HUB20260367
- Acronym
- PRIME
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ullrich F, Brockelmann PJ, Turki AT, Khan AM, Chiru ED, Vetter M, Tresckow BV, Wirth R, Cordoba R, Ortiz-Maldonado V, Fulop T, Neuendorff NR. Impact of immunological aging on T cell-mediated therapies in older adults with multiple myeloma and lymphoma. J Immunother Cancer. 2024 Dec 2;12(12):e009462. doi: 10.1136/jitc-2024-009462.
PubMed 39622581Cortes-Selva D, Perova T, Skerget S, Vishwamitra D, Stein S, Boominathan R, Lau O, Calara-Nielsen K, Davis C, Patel J, Banerjee A, Stephenson T, Uhlar C, Kobos R, Goldberg J, Pei L, Trancucci D, Girgis S, Wang Lin SX, Wu LS, Moreau P, Usmani SZ, Bahlis NJ, van de Donk NWCJ, Verona RI. Correlation of immune fitness with response to teclistamab in relapsed/refractory multiple myeloma in the MajesTEC-1 study. Blood. 2024 Aug 8;144(6):615-628. doi: 10.1182/blood.2023022823.
PubMed 38657201Bruins WSC, Smits F, Duetz C, Groen K, Korst CLBM, de Jonge AV, Verkleij CPM, Rentenaar R, Cosovic M, Eken M, Twickler I, Homan-Weert PM, Sonneveld P, Moreau P, Claesen J, van de Donk NWCJ, Zweegman S, Mutis T. A T-cell-based metric of immune age predicts outcomes in older patients with myeloma receiving daratumumab-based therapy. Blood. 2025 Nov 20;146(21):2517-2530. doi: 10.1182/blood.2025028587.
PubMed 40829164Prabhala RH, Pelluru D, Fulciniti M, Prabhala HK, Nanjappa P, Song W, Pai C, Amin S, Tai YT, Richardson PG, Ghobrial IM, Treon SP, Daley JF, Anderson KC, Kutok JL, Munshi NC. Elevated IL-17 produced by TH17 cells promotes myeloma cell growth and inhibits immune function in multiple myeloma. Blood. 2010 Jul 1;115(26):5385-92. doi: 10.1182/blood-2009-10-246660. Epub 2010 Apr 15.
PubMed 20395418Mehta PH, Fiorenza S, Koldej RM, Jaworowski A, Ritchie DS, Quinn KM. T Cell Fitness and Autologous CAR T Cell Therapy in Haematologic Malignancy. Front Immunol. 2021 Nov 25;12:780442. doi: 10.3389/fimmu.2021.780442. eCollection 2021.
PubMed 34899742Liu Z, Liang Q, Ren Y, Guo C, Ge X, Wang L, Cheng Q, Luo P, Zhang Y, Han X. Immunosenescence: molecular mechanisms and diseases. Signal Transduct Target Ther. 2023 May 13;8(1):200. doi: 10.1038/s41392-023-01451-2.
PubMed 37179335Rodriguez IJ, Lalinde Ruiz N, Llano Leon M, Martinez Enriquez L, Montilla Velasquez MDP, Ortiz Aguirre JP, Rodriguez Bohorquez OM, Velandia Vargas EA, Hernandez ED, Parra Lopez CA. Immunosenescence Study of T Cells: A Systematic Review. Front Immunol. 2021 Jan 15;11:604591. doi: 10.3389/fimmu.2020.604591. eCollection 2020.
PubMed 33519813Cai L, Zuo L, Wang G, Li Q, Ma C, Wu J, Sun C, Hu Y. T Cells Dysfunction in Multiple Myeloma. Immunotargets Ther. 2025 Sep 11;14:997-1014. doi: 10.2147/ITT.S534784. eCollection 2025.
PubMed 40959595Philipp N, Kazerani M, Nicholls A, Vick B, Wulf J, Straub T, Scheurer M, Muth A, Hanel G, Nixdorf D, Sponheimer M, Ohlmeyer M, Lacher SM, Brauchle B, Marcinek A, Rohrbacher L, Leutbecher A, Rejeski K, Weigert O, von Bergwelt-Baildon M, Theurich S, Kischel R, Jeremias I, Bucklein V, Subklewe M. T-cell exhaustion induced by continuous bispecific molecule exposure is ameliorated by treatment-free intervals. Blood. 2022 Sep 8;140(10):1104-1118. doi: 10.1182/blood.2022015956.
PubMed 35878001Bruins WSC, Smits F, Duetz C, Nasserinejad K, Groen K, Korst CLBM, de Jonge AV, Rentenaar R, Hageman T, Cosovic M, Eken M, Twickler I, Homan-Weert PM, Verkleij CPM, Frerichs K, Levin MD, van der Spek E, Nijhof IS, van Kampen R, van de Donk NWCJ, Zweegman S, Mutis T. Immune signatures in older patients with newly diagnosed multiple myeloma are associated with survival outcomes of first-line therapy irrespective of frailty levels. Hemasphere. 2025 Oct 5;9(10):e70210. doi: 10.1002/hem3.70210. eCollection 2025 Oct.
PubMed 41054769Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27.
PubMed 25628469Lin Y, Qiu L, Usmani S, Joo CW, Costa L, Derman B, Du J, Einsele H, Fernandez de Larrea C, Hajek R, Ho PJ, Kastritis E, Martinez-Lopez J, Mateos MV, Mikhael J, Moreau P, Nagarajan C, Nooka A, O'Dwyer M, Schjesvold F, Sidana S, van de Donk NW, Weisel K, Zweegman S, Raje N, Otero PR, Anderson LD Jr, Kumar S, Martin T; International Myeloma Working Group. Consensus guidelines and recommendations for the management and response assessment of chimeric antigen receptor T-cell therapy in clinical practice for relapsed and refractory multiple myeloma: a report from the International Myeloma Working Group Immunotherapy Committee. Lancet Oncol. 2024 Aug;25(8):e374-e387. doi: 10.1016/S1470-2045(24)00094-9. Epub 2024 May 28.
PubMed 38821074Dimopoulos MA, Terpos E, Boccadoro M, Moreau P, Mateos MV, Zweegman S, Cook G, Engelhardt M, Delforge M, Hajek R, Schjesvold F, Gay F, Manier S, Weisel KC, Kaiser M, van de Donk NWCJ, Zamagni E, Rodriguez-Otero P, Perrot A, Driessen C, Bila J, Laane E, Dytfeld D, Touzeau C, Beksac M, Raab MS, Cavo M, Mohty M, Spencer A, Ludwig H, Einsele H, San-Miguel J, Sonneveld P. EHA-EMN Evidence-Based Guidelines for diagnosis, treatment and follow-up of patients with multiple myeloma. Nat Rev Clin Oncol. 2025 Sep;22(9):680-700. doi: 10.1038/s41571-025-01041-x. Epub 2025 Jul 7.
PubMed 40624367
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Response Related to IMmune Age T Cell Fitness in Elderly Patients With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07674498
- Acronym / sponsor ID
- PRIME / HUB20260367
- Conditions
- Myeloma Multiple
- Keywords
- multiple myeloma, immunosenescence, Exhaustion, T-fitness, T lymphocyte, elderly, T cell therapies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall | Other | Other: immunophenotyping of lymphocyteImmunophenotyping arm |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥ 65 years old
- Relapsed/refractory multiple myeloma
- Eligible for a CAR-T cell or bispecific antibody therapies
Key exclusion criteria (4 listed)
- <65 years old
- Active cancer other than myeloma
- Active AL amyloidosis
- Central nervous system (CNS) involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunophenotyping of lymphocyteMultiparametric 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. | Other | Overall |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 39622581Ullrich F, Brockelmann PJ, Turki AT, Khan AM, Chiru ED, Vetter M, Tresckow BV, Wirth R, Cordoba R, Ortiz-Maldonado V, Fulop T, Neuendorff NR. Impact of immunological aging on T cell-mediated therapies in older adults with multiple myeloma and lymphoma. J Immunother Cancer. 2024 Dec 2;12(12):e009462. doi: 10.1136/jitc-2024-009462.
- Background: PubMed 38657201Cortes-Selva D, Perova T, Skerget S, Vishwamitra D, Stein S, Boominathan R, Lau O, Calara-Nielsen K, Davis C, Patel J, Banerjee A, Stephenson T, Uhlar C, Kobos R, Goldberg J, Pei L, Trancucci D, Girgis S, Wang Lin SX, Wu LS, Moreau P, Usmani SZ, Bahlis NJ, van de Donk NWCJ, Verona RI. Correlation of immune fitness with response to teclistamab in relapsed/refractory multiple myeloma in the MajesTEC-1 study. Blood. 2024 Aug 8;144(6):615-628. doi: 10.1182/blood.2023022823.
- Background: PubMed 40829164Bruins WSC, Smits F, Duetz C, Groen K, Korst CLBM, de Jonge AV, Verkleij CPM, Rentenaar R, Cosovic M, Eken M, Twickler I, Homan-Weert PM, Sonneveld P, Moreau P, Claesen J, van de Donk NWCJ, Zweegman S, Mutis T. A T-cell-based metric of immune age predicts outcomes in older patients with myeloma receiving daratumumab-based therapy. Blood. 2025 Nov 20;146(21):2517-2530. doi: 10.1182/blood.2025028587.
- Background: PubMed 20395418Prabhala RH, Pelluru D, Fulciniti M, Prabhala HK, Nanjappa P, Song W, Pai C, Amin S, Tai YT, Richardson PG, Ghobrial IM, Treon SP, Daley JF, Anderson KC, Kutok JL, Munshi NC. Elevated IL-17 produced by TH17 cells promotes myeloma cell growth and inhibits immune function in multiple myeloma. Blood. 2010 Jul 1;115(26):5385-92. doi: 10.1182/blood-2009-10-246660. Epub 2010 Apr 15.
- Background: PubMed 34899742Mehta PH, Fiorenza S, Koldej RM, Jaworowski A, Ritchie DS, Quinn KM. T Cell Fitness and Autologous CAR T Cell Therapy in Haematologic Malignancy. Front Immunol. 2021 Nov 25;12:780442. doi: 10.3389/fimmu.2021.780442. eCollection 2021.
- Background: PubMed 37179335Liu Z, Liang Q, Ren Y, Guo C, Ge X, Wang L, Cheng Q, Luo P, Zhang Y, Han X. Immunosenescence: molecular mechanisms and diseases. Signal Transduct Target Ther. 2023 May 13;8(1):200. doi: 10.1038/s41392-023-01451-2.
- Background: PubMed 33519813Rodriguez IJ, Lalinde Ruiz N, Llano Leon M, Martinez Enriquez L, Montilla Velasquez MDP, Ortiz Aguirre JP, Rodriguez Bohorquez OM, Velandia Vargas EA, Hernandez ED, Parra Lopez CA. Immunosenescence Study of T Cells: A Systematic Review. Front Immunol. 2021 Jan 15;11:604591. doi: 10.3389/fimmu.2020.604591. eCollection 2020.
- Background: PubMed 40959595Cai L, Zuo L, Wang G, Li Q, Ma C, Wu J, Sun C, Hu Y. T Cells Dysfunction in Multiple Myeloma. Immunotargets Ther. 2025 Sep 11;14:997-1014. doi: 10.2147/ITT.S534784. eCollection 2025.
- Background: PubMed 35878001Philipp N, Kazerani M, Nicholls A, Vick B, Wulf J, Straub T, Scheurer M, Muth A, Hanel G, Nixdorf D, Sponheimer M, Ohlmeyer M, Lacher SM, Brauchle B, Marcinek A, Rohrbacher L, Leutbecher A, Rejeski K, Weigert O, von Bergwelt-Baildon M, Theurich S, Kischel R, Jeremias I, Bucklein V, Subklewe M. T-cell exhaustion induced by continuous bispecific molecule exposure is ameliorated by treatment-free intervals. Blood. 2022 Sep 8;140(10):1104-1118. doi: 10.1182/blood.2022015956.
- Background: PubMed 41054769Bruins WSC, Smits F, Duetz C, Nasserinejad K, Groen K, Korst CLBM, de Jonge AV, Rentenaar R, Hageman T, Cosovic M, Eken M, Twickler I, Homan-Weert PM, Verkleij CPM, Frerichs K, Levin MD, van der Spek E, Nijhof IS, van Kampen R, van de Donk NWCJ, Zweegman S, Mutis T. Immune signatures in older patients with newly diagnosed multiple myeloma are associated with survival outcomes of first-line therapy irrespective of frailty levels. Hemasphere. 2025 Oct 5;9(10):e70210. doi: 10.1002/hem3.70210. eCollection 2025 Oct.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 25628469Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunophenotyping of lymphocyte in people with Myeloma Multiple, run by Jules Bordet Institute at 3 sites in Belgium.
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 3 inclusion and 4 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Contact Marie Vercruyssen, MD (+32497840746, marie.vercruyssen@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ≥VGPR or better according to IMWG criteria at 3 months. (time frame: 3 months after the treatment). 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 NCT07674498, which also lists 14 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 29 Jun 2026.