Not yet recruiting NCT07045168
Risk-adapted Therapeutic Strategy in +1q NDMM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: risk-scoring model.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study
Overview
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.
Interventions
- Other risk-scoring model
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 were classified into low- (0 point),intermediate- (1-3 points), and high-risk (4-7 points) groups.
Primary outcome measures
- MRD negativity rate [Time frame: through study completion, up to 2 years]
- sustained MRD negativity rate [Time frame: through study completion, up to 2 years]
- Progression-Free Survival (PFS) [Time frame: through study completion, up to 2 years]
- Overall Survival (OS) [Time frame: through study completion, up to 2 years]
- objective response rate [Time frame: through study completion, up to 2 years]
- Treatment related adverse event(TRAE) [Time frame: through study completion, up to 2 years]
Secondary outcome measures (4)
- differences between MRD-negative and MRD-positive patients [Time frame: through study completion, up to 2 years]
- elderly +1q NDMM patients [Time frame: through study completion, up to 2 years]
- The efficacy of 1q negativity patients [Time frame: through study completion, up to 2 years]
- The survival of 1q negativity patients [Time frame: through study completion, up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Hospital of Jilin University — Changchun
Publications
- van 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
- Zamagni 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
- Kumar 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
- Sonneveld 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. PMID 27002115
- Croft 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. 2 PMID 33262523
- Wu 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
- D'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 Int PMID 35605179
- Abdallah NH, Binder M, Rajkumar SV, Greipp PT, Kapoor P, Dispenzieri A, Gertz MA, Baughn LB, Lacy MQ, Hayman SR, Buadi FK, Dingli D, Go RS, Hwa YL, Fonder AL, Hobbs MA, Lin Y, Leung N, Kourelis T, Warsame R, Siddiqui MA, Kyle RA, Bergsagel PL, Fonseca R, Ketterling RP, Kumar SK. A simple additive staging system for newly diagnosed multiple myeloma. Blood Cancer J. 2022 Jan 31;12(1):21. doi: 10.103 PMID 35102148
Identifiers
NCT: NCT07045168 · Risk-adapted therapy