Clinical trial · Interventional
Immune Fitness in Older Patients With Relapsed and Refractory Multiple Myeloma
Prediction of Response Related to IMmune Age T Cell Fitness in Elderly Patients With Relapsed and Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma Multiple | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunophenotyping of lymphocyte | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Overall
- description
- Immunophenotyping arm
- interventionNames
- Other: immunophenotyping of lymphocyte
Primary outcomes (1)
- measure
- Rate of ≥VGPR or better according to IMWG criteria at 3 months.
- timeFrame
- 3 months after the treatment
- description
- The association of VGPR and immune profile will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (14)
- BACKGROUNDUllrich 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. PMID 39622581
- BACKGROUNDCortes-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. PMID 38657201
- BACKGROUNDBruins 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. PMID 40829164
- BACKGROUNDPrabhala 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. PMID 20395418
- BACKGROUNDMehta 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. PMID 34899742
- BACKGROUNDLiu 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.