Risk-adapted Therapeutic Strategy in +1q NDMM

NCT07045168 | Not Yet Recruiting DMC

• 1 other identifier: Risk-adapted therapy
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Myeloma

Keywords

Multiple Myeloma; Risk-adapted therapeutic strategy; +1q MM; high-risk MM; minimal residual disease

Outcome Measures

Primary Outcomes (6)

• MRD negativity rate

  To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.

  through study completion, up to 2 years

• sustained MRD negativity rate

  To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.

  through study completion, up to 2 years

• Progression-Free Survival (PFS)

  PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death

  through study completion, up to 2 years

• Overall Survival (OS)

  OS were calculated from the time of enrollment to death or the last follow-up

  through study completion, up to 2 years

• objective response rate

  To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).

  through study completion, up to 2 years

• Treatment related adverse event(TRAE)

  Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.

  through study completion, up to 2 years

Secondary Outcomes (4)

• differences between MRD-negative and MRD-positive patients

  through study completion, up to 2 years

• elderly +1q NDMM patients

  through study completion, up to 2 years

• The efficacy of 1q negativity patients

  through study completion, up to 2 years

• The survival of 1q negativity patients

  through study completion, up to 2 years

Study Arms (4)

low-risk +1q NDMM patients

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) .

Other: risk-scoring model

intermediate/high-risk +1q NDMM patients

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.

Other: risk-scoring model

1q negativity low-risk group

Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.

1q negativity high-risk group

Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.

Interventions

risk-scoring model OTHER

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.

Also known as: Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma

intermediate/high-risk +1q NDMM patients; low-risk +1q NDMM patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed NDMM by 2014 IMWG criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FengYan Jin: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1182/blood-2016-01-631200. Epub 2016 Mar 21.

  PMID: 27002115 BACKGROUND

• 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. 2021 Jul;35(7):2043-2053. doi: 10.1038/s41375-020-01096-y. Epub 2020 Dec 1.

  PMID: 33262523 BACKGROUND

• 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 BACKGROUND

• 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 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.

  PMID: 35605179 BACKGROUND

• 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: 10.1038/s41408-022-00611-x.

  PMID: 35102148 BACKGROUND

• Walker BA, Mavrommatis K, Wardell CP, Ashby TC, Bauer M, Davies F, Rosenthal A, Wang H, Qu P, Hoering A, Samur M, Towfic F, Ortiz M, Flynt E, Yu Z, Yang Z, Rozelle D, Obenauer J, Trotter M, Auclair D, Keats J, Bolli N, Fulciniti M, Szalat R, Moreau P, Durie B, Stewart AK, Goldschmidt H, Raab MS, Einsele H, Sonneveld P, San Miguel J, Lonial S, Jackson GH, Anderson KC, Avet-Loiseau H, Munshi N, Thakurta A, Morgan G. A high-risk, Double-Hit, group of newly diagnosed myeloma identified by genomic analysis. Leukemia. 2019 Jan;33(1):159-170. doi: 10.1038/s41375-018-0196-8. Epub 2018 Jul 2.

  PMID: 29967379 BACKGROUND

• Yang P, Chen H, Liang X, Xu W, Yu S, Huang W, Yi X, Guo Q, Tian M, Yue T, Li M, Zhang Y, Zhang M, Yan Y, Hu Z, Kumar SK, Zhou F, Dai Y, Jin F. Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma. Am J Hematol. 2023 Feb;98(2):251-263. doi: 10.1002/ajh.26774. Epub 2022 Nov 8.

  PMID: 36309982 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood、bone marrow

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Hospital of Jilin University

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 1, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): July 4, 2029
• Last Updated: September 15, 2025

Record last verified: 2025-06

Locations

CN (1)