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Study of Lenalidomide and Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma

NCT01593410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2017-09-20

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of lenalidomide plus low-dose dexamethasone in Chinese subjects with relapsed or refractory multiple myeloma.

Even though the efficacy and safety of lenalidomide has already been well-demonstrated in other populations including Asians, this study will assess the efficacy and safety as well as pharmacokinetics of lenalidomide in Chinese subjects. In addition, this study will generate clinically meaningful information in guiding the therapeutic use of lenalidomide for Chinese subjects.

Conditions

Interventions

DRUG

Lenalidomide

25 mg oral lenalidomide once daily on Days 1-21 every 28 days

DRUG

Dexamethasone

Cycle 1: 40 mg oral dexamethasone once daily on Days 8, 15, and 22. Cycle 2 and beyond: 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Jay Mei, M.D. · Celgene

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-01
Primary Completion
2013-01-03
Completion
2013-01-03

Countries

  • China

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 NCT01593410 on ClinicalTrials.gov