NCT05722405 Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
| NCT ID | NCT05722405 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Yang Xu, Dr.
STUDY DIRECTOR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT05722405 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05722405 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05722405 currently recruiting?
Yes, NCT05722405 is actively recruiting participants. Contact the research team at zxzzju@zju.edu.cn for enrollment information.
Where is the NCT05722405 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05722405 clinical trial?
NCT05722405 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Yang Xu, Dr. at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 100 participants.