MedTrace Logo

Lenalidomide & High Dose Dexamethasone for Untreated Multiple Myeloma Renal Failure Patients

NCT01270932 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-12-29

No results posted yet for this study

Summary

Primary:

• To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma) patients with various degrees of renal failure using pharmacokinetic studies

Secondary:

* To evaluate the safety of lenalidomide and dexamethasone as induction therapy in newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified dosing guidelines
* To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using the modified dosing guidelines
* To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure

Conditions

Interventions

DRUG

Lenalidomide and Dexamethasone

Lenalidomide:Daily for 21 days of a 28 day cycle Dexamethasone:Days 1-4, 9-12, 17-20 for the first cycle and then weekly dexamethasone from cycles 2-4.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2017-12-18
Completion
2017-12-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT01270932 on ClinicalTrials.gov