Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT05722405

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-05

100

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

A

Affiliated Hospital of Jiaxing University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of symptomatic multiple myeloma with high-risk genetic features according to IMWG 2016 criteria
  • ECOG performance status between 0 and 3
  • Completed induction and consolidation of VRD regimen; for eligible patients under 65, stem cell collection and autologous transplant as planned
  • Expected survival longer than 6 months
  • Age between 18 and 80 years
  • Adequate kidney, liver, lung, and heart function as defined by specific lab and clinical criteria
  • Negative pregnancy tests for women of childbearing potential; strict contraception required if treated with lenalidomide
  • Ability to comply with the study protocol
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous treatment
  • Known HIV infection or untreated hepatitis B or C infections
  • History of thrombosis within the past 6 months
  • History of malignancy other than certain in situ cancers unless disease-free for at least 3 years
  • Uncontrolled heart rhythm problems or significant cardiac disease within 12 months
  • Significant immunodeficiency
  • Medical conditions interfering with safety or efficacy assessments
  • History of severe allergic reactions to study drugs
  • Pregnant or breastfeeding women of childbearing potential
  • Unwillingness to use birth control during the study and for 6 months after
  • Inability to complete all study visits or follow-up
  • Autoimmune diseases causing organ damage or requiring systemic immunosuppressive treatment within 2 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Yang Xu

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

Loading map...

Research Team

X

Xuzhao Zhang, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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