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Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone

NCT03809780 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-06-22

No results posted yet for this study

Summary

Recent prospective multicenter phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15mg) and dexamethasone (20mg) in frail patients with relapsed or refractory MM. The overall response rate was 71% including complete remission of 15%. Median progression free survival and overall survival were 8.9 and 30.5 months. In addition, grade 3-4 toxicities such as neutropenia, and infections were reduced. This study supported that lower dose lenalidomide may be optimal stating dose for elderly patients with frailty.

Conditions

Interventions

DRUG

Lenalidomide

-high dose: \[lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly\] -Low dose: \[lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly\]

DRUG

Dexamethasone

-high dose: \[lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly\] -Low dose: \[lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly\]

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Kosin University Gospel Hospital

    lead OTHER

Principal Investigators

  • Ho Sup Lee, MD, PhD. · Kosin University Gospel Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809780 on ClinicalTrials.gov