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Trial Title:
Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
NCT ID:
NCT05722405
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lenalidomide
Ixazomib
Glycine
Conditions: Keywords:
high risk multiple myeloma
Ixazomib
low-dose lenalidomide
maintenance therapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ixazomib plus low-dose lenalidomide
Description:
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
Arm group label:
Ixazomib plus low-dose lenalidomide
Intervention type:
Drug
Intervention name:
Ixazomib
Description:
Ixazomib alone
Arm group label:
Ixazomib
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yang Xu
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Xu, MD,PhD
Phone:
+86-89713674
Email:
yxu@zju.edu.cn
Contact backup:
Last name:
Xuzhao Zhang, MD,PhD
Phone:
086-15868881531
Email:
zxzzju@zju.edu.cn
Start date:
July 1, 2022
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Jiaxing University
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Collaborator:
Agency:
Lishui Country People's Hospital
Agency class:
Other
Collaborator:
Agency:
Dongyang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shangyu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shaoxing People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shaoxing Second Hospital
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05722405
