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Exploratory Study of Ixazomib in Combination With Reduced Dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• ECOG 0-3

• 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.

• Expected survival beyond 6 months

• Age 18 to 80 years.

• 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

• 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.

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

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

Locations
Other Locations
China
Yang Xu
RECRUITING
Hangzhou
Contact Information
Primary
Xuzhao Zhang, Dr.
zxzzju@zju.edu.cn
(086)571-89713679
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 100
Treatments
Other: Ixazomib
Ixazomib as the single drug for maintenance. This group as control arm
Experimental: Ixazomib plus low-dose lenalidomide
Ixazomib combined with low-dose lenalidomide(10mg) for maintenance
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Shaoxing Second Hospital, Dongyang People's Hospital, Huzhou Central Hospital, Shaoxing People's Hospital, Lishui Country People's Hospital, Shangyu People's Hospital, Affiliated Hospital of Jiaxing University

This content was sourced from clinicaltrials.gov

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