Clinical trial · Observational
Risk-adapted Therapeutic Strategy in +1q NDMM
Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study
NCT07045168CI-TRIAL-00095080not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| risk-scoring model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- low-risk +1q NDMM patients
- description
- This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting International Staging System (ISS) stage III, hypercalcemia, high lactate dehydrogenase (LDH), and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point) .
- interventionNames
- Other: risk-scoring model
- label
- intermediate/high-risk +1q NDMM patients
- description
- This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q was classified into intermediate- (1-3 points) and high-risk (4-7 points) groups.
- interventionNames
- Other: risk-scoring model
- label
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Age \>=18, or \>=65 and fit according to IMWG-FI. * Newly diagnosed NDMM by 2014 IMWG criteria. * Adequate organ function for systemic therapy. * Signed informed consent. Exclusion Criteria: * Active infections requiring systemic treatment. * Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias. * History of hematologic or solid tumors treated with chemo/radiotherapy within 5 years. * Current malignancies requiring therapy. * Refusal to participate.
References
Publications (10)
- BACKGROUNDvan de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427. doi: 10.1016/S0140-6736(21)00135-5. PMID 33516340
- BACKGROUNDZamagni E, Barbato S, Cavo M. How I treat high-risk multiple myeloma. Blood. 2022 May 12;139(19):2889-2903. doi: 10.1182/blood.2020008733. PMID 34727187
- BACKGROUNDKumar SK, Rajkumar SV. The multiple myelomas - current concepts in cytogenetic classification and therapy. Nat Rev Clin Oncol. 2018 Jul;15(7):409-421. doi: 10.1038/s41571-018-0018-y. PMID 29686421
- BACKGROUNDSonneveld P, Avet-Loiseau H, Lonial S, Usmani S, Siegel D, Anderson KC, Chng WJ, Moreau P, Attal M, Kyle RA, Caers J, Hillengass J, San Miguel J, van de Donk NW, Einsele H, Blade J, Durie BG, Goldschmidt H, Mateos MV, Palumbo A, Orlowski R. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group. Blood. 2016 Jun 16;127(24):2955-62. doi: 10.1182/blood-2016-01-631200. Epub 2016 Mar 21. PMID 27002115
- BACKGROUNDCroft J, Ellis S, Sherborne AL, Sharp K, Price A, Jenner MW, Drayson MT, Owen RG, Chown S, Lindsay J, Karunanithi K, Hunter H, Gregory WM, Davies FE, Morgan GJ, Cook G, Atanesyan L, Savola S, Cairns DA, Jackson G, Houlston RS, Kaiser MF. Copy number evolution and its relationship with patient outcome-an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial. Leukemia. 2021 Jul;35(7):2043-2053. doi: 10.1038/s41375-020-01096-y. Epub 2020 Dec 1. PMID 33262523
- BACKGROUNDWu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese. PMID 30704229
- BACKGROUNDD'Agostino M, Cairns DA, Lahuerta JJ, Wester R, Bertsch U, Waage A, Zamagni E, Mateos MV, Dall'Olio D, van de Donk NWCJ, Jackson G, Rocchi S, Salwender H, Blade Creixenti J, van der Holt B, Castellani G, Bonello F, Capra A, Mai EK, Durig J, Gay F, Zweegman S, Cavo M, Kaiser MF, Goldschmidt H, Hernandez Rivas JM, Larocca A, Cook G, San-Miguel JF, Boccadoro M, Sonneveld P. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project. J Clin Oncol. 2022 Oct 10;40(29):3406-3418. doi: 10.1200/JCO.21.02614. Epub 2022 May 23.