Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not

NCT06463717 | Recruiting

• 1 other identifier: IIT20230339B-R1
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction. The main question it aims to answer is: In primary multiple myeloma patients who achieved MRD negativity after induction, non ASCT regimens are not inferior to ASCT or not? Participants will receive ASCT or non ASCT regimen according to their own choice. Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety.

Conditions

Multiple Myeloma; Minimal Residual Disease

Keywords

Minimal Residual Disease Negativity; Autologous Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Progression-free survival is defined as the duration from diagnosis to the date of death, initial progression, or the last follow-up

  2-year

Secondary Outcomes (2)

• sustain MRD negativity

  1-year, 2-year

• Number of Participants With Treatment-Related Adverse Events

  Once enrolled, an average of 2 year

Study Arms (2)

ASCT regimen

Primary multiple myeloma patients who receive autologous hematopoietic stem-cell transplantation (ASCT) after they achieved MRD negativity after induction

Drug: Transplant, Autologous

non ASCT regimen

Primary multiple myeloma patients who receive non autologous hematopoietic stem-cell transplantation (ASCT) regimen such as 4-6 cycles of bortezomib-lenalidomide-dexamethasone after they achieved MRD negativity after induction

Drug: Chemotherapy drug

Interventions

Transplant, Autologous DRUG

High-dose melphalan followed by autologous stem cell transplantation

Also known as: ASCT

ASCT regimen

Chemotherapy drug DRUG

Regimen such as Bortezomib plus Lenalidomide plus Dexamethasone

Also known as: Non ASCT regimen

non ASCT regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary multiple myeloma who achieved MRD negativity after induction therapy are screened by the eligibility Criteria

You may qualify if:

• Newly diagnosed multiple myeloma according to the criteria of International Working Group of Myeloma
• Age ranges from 18-70 years old
• Achieved MRD negativity and at least very good partial response in clinical response after 4-6 courses of induction therapy. MRD is measured by MRD by multicolor flow with a sensitivity of 10-5.
• At enrollment, score of Eastern Cooperative Oncology Group (ECOG) should be 0-2.
• Organ function requirement: Blood bilirubin ≤ 2mg/dL (35 μ mol/L), Alanine aminotransferase/Aspartate aminotransferase below 2 times the upper limit of normal value, Creatinine clearance rate (Ccr) ≥ 30ml/min and Cardiac ejection fraction ≥50%.
• Expected survival more than 3 months.

You may not qualify if:

• Two or more high-risk cytogenetic abnormalities, including del (17p), t (4; 14), t (14; 16), del (1p), amp (1q). Fluorescence in situ hybridization was used to analyze CD138 positive sorted cells, with cut off value of 15% for translocation, 10% for deletion, and amp (1q) of 20%.
• Extracellular plasma cell disease, central invasion of myeloma, plasma cell leukemia
• History of other malignant tumors within the past 5 years
• Patients with HIV, active tuberculosis, clinically active hepatitis A, B, or C
• Other serious condition that may restrict patients from continuing treatment (such as advanced infection, uncontrolled diabetes, severe cardiac insufficiency, or angina pectoris)
• General condition not suitable for chemotherapy
• Pregnant or lactating women
• Suffering from other serious organic diseases and mental disorders.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The Affiliated Hospital of Medical College, Ningbo University: collaborator
• Dongyang People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• Gay F, Musto P, Rota-Scalabrini D, Bertamini L, Belotti A, Galli M, Offidani M, Zamagni E, Ledda A, Grasso M, Ballanti S, Spadano A, Cea M, Patriarca F, D'Agostino M, Capra A, Giuliani N, de Fabritiis P, Aquino S, Palmas A, Gamberi B, Zambello R, Petrucci MT, Corradini P, Cavo M, Boccadoro M. Carfilzomib with cyclophosphamide and dexamethasone or lenalidomide and dexamethasone plus autologous transplantation or carfilzomib plus lenalidomide and dexamethasone, followed by maintenance with carfilzomib plus lenalidomide or lenalidomide alone for patients with newly diagnosed multiple myeloma (FORTE): a randomised, open-label, phase 2 trial. Lancet Oncol. 2021 Dec;22(12):1705-1720. doi: 10.1016/S1470-2045(21)00535-0. Epub 2021 Nov 11.

  PMID: 34774221 BACKGROUND

• Cavo M, Gay F, Beksac M, Pantani L, Petrucci MT, Dimopoulos MA, Dozza L, van der Holt B, Zweegman S, Oliva S, van der Velden VHJ, Zamagni E, Palumbo GA, Patriarca F, Montefusco V, Galli M, Maisnar V, Gamberi B, Hansson M, Belotti A, Pour L, Ypma P, Grasso M, Croockewit A, Ballanti S, Offidani M, Vincelli ID, Zambello R, Liberati AM, Andersen NF, Broijl A, Troia R, Pascarella A, Benevolo G, Levin MD, Bos G, Ludwig H, Aquino S, Morelli AM, Wu KL, Boersma R, Hajek R, Durian M, von dem Borne PA, Caravita di Toritto T, Zander T, Driessen C, Specchia G, Waage A, Gimsing P, Mellqvist UH, van Marwijk Kooy M, Minnema M, Mandigers C, Cafro AM, Palmas A, Carvalho S, Spencer A, Boccadoro M, Sonneveld P. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study. Lancet Haematol. 2020 Jun;7(6):e456-e468. doi: 10.1016/S2352-3026(20)30099-5. Epub 2020 Apr 30.

  PMID: 32359506 BACKGROUND

• Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, Arnulf B, Macro M, Belhadj K, Garderet L, Roussel M, Payen C, Mathiot C, Fermand JP, Meuleman N, Rollet S, Maglio ME, Zeytoonjian AA, Weller EA, Munshi N, Anderson KC, Richardson PG, Facon T, Avet-Loiseau H, Harousseau JL, Moreau P; IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. N Engl J Med. 2017 Apr 6;376(14):1311-1320. doi: 10.1056/NEJMoa1611750.

  PMID: 28379796 BACKGROUND

• Yong K, Wilson W, de Tute RM, Camilleri M, Ramasamy K, Streetly M, Sive J, Bygrave CA, Benjamin R, Chapman M, Chavda SJ, Phillips EH, Del Mar Cuadrado M, Pang G, Jenner R, Dadaga T, Kamora S, Cavenagh J, Clifton-Hadley L, Owen RG, Popat R. Upfront autologous haematopoietic stem-cell transplantation versus carfilzomib-cyclophosphamide-dexamethasone consolidation with carfilzomib maintenance in patients with newly diagnosed multiple myeloma in England and Wales (CARDAMON): a randomised, phase 2, non-inferiority trial. Lancet Haematol. 2023 Feb;10(2):e93-e106. doi: 10.1016/S2352-3026(22)00350-7. Epub 2022 Dec 15.

  PMID: 36529145 BACKGROUND

• Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.

  PMID: 27511158 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

Interventions

Transplantation, Autologous

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

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Haitao Meng

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangshun You

CONTACT

+86 15088687797; youliangshun@zju.edu.cn

Qiumei Yao

CONTACT

+86 13867490514; qiumei_yao@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 18, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 24, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)