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RecruitingNCT05477797

Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma.

Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma: a Prospective, Randomized, Controlled, Multicenter Clinical Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
420 (estimated)
Sponsor
RenJi Hospital · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

Newly Diagnosed Myeloma Patients, who achieved efficacy above VGPR (very good PR)after initial treatment were enrolled. Patients were then randomly assigned to Id and Rd groups for maintenance treatment. Therapeutic effectiveness will be reviewed monthly until intolerant side effect or disease progression appear . The follow-up period is approximately 2 years.

Detailed description

Newly Diagnosed Myeloma Patients, who achieved efficacy above VGPR after initial treatment were enrolled. Patients were then randomly assigned to Id and Rd groups for maintenance treatment. Therapeutic effectiveness will be reviewed monthly until intolerant side effect or disease progression appear . The follow-up period is approximately 2 years. Progression-free survival (PFS)was defined as the duration from randomization to the first evidence of disease progression or death from any cause. Overall survival (OS) was defined as the duration from the randomization to death from any cause. The Kaplan-Meier method was employed to plot the survival curves, with the log-rank test to assess the differences.

Conditions

Interventions

TypeNameDescription
DRUGIxazomib DX/Lenalidomide DXAfter assessment of risk stratification,patients will be assigned to Id or Rd group randomly for maintenance therapy. Then they will be reviewed the efficacy monthly.

Timeline

Start date
2023-02-16
Primary completion
2026-01-15
Completion
2026-01-15
First posted
2022-07-28
Last updated
2024-04-15

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05477797. Inclusion in this directory is not an endorsement.