Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma

NCT ID: NCT05722405

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2028-07-31

Brief Summary

Ixazomib combined with low-dose lenalidomide(10mg) vs Ixazomib alone as maintenance regimen in patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.

Detailed Description

This study was designed to investigate whether the oral proteasome inhibitor ixazomib combined with low-dose lenalidomide(10mg) as a maintenance regimen could improve the outcome and prognosis of patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ixazomib

Ixazomib as the single drug for maintenance. This group as control arm

Group Type: OTHER

Ixazomib

Intervention Type: DRUG

Ixazomib alone

Ixazomib plus low-dose lenalidomide

Ixazomib combined with low-dose lenalidomide(10mg) for maintenance

Group Type: EXPERIMENTAL

Ixazomib plus low-dose lenalidomide

Intervention Type: DRUG

Whether Ixazomib combined with low-dose lenalidomide improves the outcome and prognosis of patients with high-risk multiple myeloma as a maintenance treatment option compared to ixazolomib alone

Interventions

Ixazomib plus low-dose lenalidomide

Whether Ixazomib combined with low-dose lenalidomide improves the outcome and prognosis of patients with high-risk multiple myeloma as a maintenance treatment option compared to ixazolomib alone

Intervention Type: DRUG

Ixazomib

Ixazomib alone

Intervention Type: DRUG

Other Intervention Names

Ninlaro; Ninlaro

Eligibility Criteria

Inclusion Criteria

1. Patients with a confirmed diagnosis of symptomatic multiple myeloma with high-risk genetic features (1q21 amplification/t(4;14)/t(14;16)/t(14;20)/17p deletion/TP53 mutation) according to IMWG 2016 criteria.

2. ECOG 0-3

3. After induction and consolidation of the VRD regimen (where patients younger than 65 years of age who are eligible for autologous HSCT and are willing to undergo autologous HSCT collect stem cells and complete autologous HSCT after 3 courses and continue bortezomib or Ixazomib continuous therapy while awaiting transplantation and complete post-transplant consolidation; patients who are not eligible for HSCT regulation or refuse to undergo autologous HSCT go directly to consolidation after induction therapy) and are willing to receive maintenance therapy.

4. Expected survival beyond 6 months

5. Age 18 to 80 years.

6. Adequate renal, hepatic, pulmonary and cardiac function, defined as follows Creatinine clearance (as estimated by Cockcroft-Gault) ≥ 60 ml/min (except for abnormal renal function due to multiple myeloma).

Serum ALT and AST below 2.5 times the upper limit of normal Total bilirubin below 1.5 times the upper limit of normal Cardiac ejection fraction ≥ 50%, no pericardial effusion confirmed by echocardiography, no clinically significant electrocardiographic findings Absence of clinically significant pleural effusion Baseline oxygen saturation ≥ 95% while indoors

7. Serum or urine pregnancy tests must be negative in women of childbearing potential (women who have undergone sterilization or are at least 2 years post-menopausal may be considered infertile), and patients treated with lenalidomide should have strict contraception and birth control measures.

8. Patients are able to comply with the trial protocol as judged by the investigator.

9. Patients voluntarily participate in this clinical trial, understand the study procedures and are able to sign the informed consent in writing.

Exclusion Criteria

1. Presence of fungal, bacterial, viral or other infections that are uncontrollable or require IV antimicrobial therapy. Presence of simple urinary tract infection and uncomplicated bacterial pharyngitis, after consultation with the investigator, if responsive to active treatment.

2. Known presence of HIV or a history of hepatitis B (HBsAg positive) or viral hepatitis C (anti-HCV positive) infection. A history of treated hepatitis B or hepatitis C is allowed if a viral load undetectable by quantitative PCR and/or nucleic acid testing is present.

3. A history of thrombosis within six months.

4. presence of a history of malignancy other than carcinoma in situ (e.g., cervical, bladder, breast, thyroid), except in patients who have not had an episode for at least 3 years

5. Patients with uncontrolled arrhythmias and a history of myocardial infarction, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.

6. The presence of a significant immunodeficiency.

7. The presence of any medical condition that may interfere with the assessment of the safety or efficacy of the investigational treatment.

8. A history of severe hypersensitivity reactions to this investigational drug.

9. Any pregnant or breastfeeding female of childbearing potential.

10. Male and female subjects who are unwilling to use birth control within 6 months from the time of signing the consent form until the completion of the administration of this study.

11. Subjects who, in the judgment of the investigator, are unlikely to complete all study visits or procedures required by the protocol, including follow-up visits or compliance with the requirements for participation in the study.

12. History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that causes end-organ damage or requires systemic immunosuppressive/systemic disease-modifying drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: collaborator

Huzhou Central Hospital

OTHER

Sponsor Role: collaborator

Lishui Country People's Hospital

OTHER

Sponsor Role: collaborator

Dongyang People's Hospital

OTHER

Sponsor Role: collaborator

Shangyu People's Hospital

OTHER

Sponsor Role: collaborator

Shaoxing People's Hospital

OTHER

Sponsor Role: collaborator

Shaoxing Second Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Xu, Dr.

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Yang Xu

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuzhao Zhang, Dr.

Role: CONTACT

zxzzju@zju.edu.cn

(086)571-89713679

Facility Contacts

Yang Xu, MD,PhD

Role: primary

yxu@zju.edu.cn

+86-89713674

Xuzhao Zhang, MD,PhD

Role: backup

zxzzju@zju.edu.cn

086-15868881531

Other Identifiers

2022-0215

Identifier Type: -

Identifier Source: org_study_id