Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients

NCT04217967 | Completed Phase 4 FDA Drug

• 1 other identifier: ZS-2129
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the real-world efficacy and safety of ixazomib, lenalidomide, or ixazomib in combination with lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma in China.

Conditions

Multiple Myeloma

Keywords

real-world; dual-drug maintenance; oral regimen

Outcome Measures

Primary Outcomes (2)

• progression-free survival

  from enrollment to first disease progression

  From date of enrollment until the date of first documented progression, assessed up to 20 months

• overall survival

  from enrollment to death with follow-up

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Study Arms (3)

Lenalidomide group

ACTIVE COMPARATOR

lenalidomide 25mg qod d1\~21 days, rest 7 days

Drug: Lenalidomide

Ixazomib group

ACTIVE COMPARATOR

ixazomib 4mg orally, once a week, 3 times a month

Drug: Ixazomib

Combination group

EXPERIMENTAL

ixazomib 4mg orally, once a week, 3 times a month lenalidomide 25mg qod d1\~21 days, rest 7 days use in combination

Drug: Ixazomib; Drug: Lenalidomide

Interventions

Ixazomib DRUG

the ixazomib group uses ixazomib as the comparator group, the combination group receives both lenalidomide and ixazomib as the experimental group

Combination group; Ixazomib group

Lenalidomide DRUG

the lenalidomide group uses lenalidomide as comparitor group and the combination group receives both lenalidomide and ixazomib

Combination group; Lenalidomide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years;
• Newly diagnosed MM patients who fulfill the diagnostic criteria of International Myeloma Working Group (IMWG) 2014 standard; transplant-ineligible or transplant eligible yet without intent for ASCT
• Maintenance treatment will start after first-line treatment or second-line treatment;
• The total courses of front-line regimens are between 4-9;
• The clinical efficacy before the enrollment is partial response (PR) or better;
• Physical performance status (ECOG) score ≤ 2;
• Patients participate in the study based on his/her own will and voluntarily sign the informed consent form

You may not qualify if:

• Patients who are allergic or intolerant to ixazomib or lenalidomide;
• patients with severe cardiopulmonary dysfunction;
• patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
• patients with other malignancies (except for carcinoma in situ);
• patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
• pregnant or lactating women;
• can not be strictly contraceptive;
• Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University Third Hospital: collaborator
• Beijing Jishuitan Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Peking University First Hospital: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Tianjin Medical University General Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Shanxi Bethune Hospital: collaborator
• Beijing Hospital: collaborator

Study Sites (1)

PekingUMCH

Beijing, Beijing Municipality, 100005, China

Location

Related Publications (7)

• Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.

  PMID: 21410373 BACKGROUND

• Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.

  PMID: 19474385 BACKGROUND

• Anderson KC. Progress and Paradigms in Multiple Myeloma. Clin Cancer Res. 2016 Nov 15;22(22):5419-5427. doi: 10.1158/1078-0432.CCR-16-0625.

  PMID: 28151709 BACKGROUND

• Gay F, Jackson G, Rosinol L, Holstein SA, Moreau P, Spada S, Davies F, Lahuerta JJ, Leleu X, Bringhen S, Evangelista A, Hulin C, Panzani U, Cairns DA, Di Raimondo F, Macro M, Liberati AM, Pawlyn C, Offidani M, Spencer A, Hajek R, Terpos E, Morgan GJ, Blade J, Sonneveld P, San-Miguel J, McCarthy PL, Ludwig H, Boccadoro M, Mateos MV, Attal M. Maintenance Treatment and Survival in Patients With Myeloma: A Systematic Review and Network Meta-analysis. JAMA Oncol. 2018 Oct 1;4(10):1389-1397. doi: 10.1001/jamaoncol.2018.2961.

  PMID: 30098165 BACKGROUND

• Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.

  PMID: 30545780 BACKGROUND

• Chakraborty R, Muchtar E, Kumar SK, Buadi FK, Dingli D, Dispenzieri A, Hayman SR, Hogan WJ, Kapoor P, Lacy MQ, Leung N, Warsame R, Kourelis T, Gonsalves W, Gertz MA. Outcomes of maintenance therapy with lenalidomide or bortezomib in multiple myeloma in the setting of early autologous stem cell transplantation. Leukemia. 2018 Mar;32(3):712-718. doi: 10.1038/leu.2017.256. Epub 2017 Aug 14.

  PMID: 28848227 BACKGROUND

• Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Rajkumar SV, Richardson PG. Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance. Leukemia. 2019 Jul;33(7):1736-1746. doi: 10.1038/s41375-019-0384-1. Epub 2019 Jan 29.

  PMID: 30696949 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ixazomib; Lenalidomide

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Junling Zhuang, MD

  Peking Union Medical College, department of hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 6, 2020
• Study Start: September 24, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication, the data will become available

Locations

CN (1)