Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma
Status:
Completed
Trial end date:
2017-09-11
Target enrollment:
Participant gender:
Summary
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in
combination with low dose dexamethasone in patients with relapsed multiple myeloma.
The investigators propose to use the need for dose reduction as a criterion to judge
tolerability from various causes. In the veteran population which predominantly is in the
older age category with number of co-morbidities, a lower dose regimen may be safer and
advantageous.
This study expects to enroll approximately 80 subjects from participating VA sites across the
nation.
The investigators will evaluate the safety of the two dose regimens by comparing frequency of
dose reductions. The investigators will also measure how long the responses last with each
dose.
Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of
specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for
patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM
are cancers of the blood. It is currently being tested in a variety of cancer conditions. In
this case it is considered experimental.
At the time of enrollment, one-half of the subjects will be chosen at random to receive the
15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide.
Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d.
or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will
be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose
reduction on the same schedule if the patient cannot tolerate the higher dose of
dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis.
Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended.
Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Phase:
Phase 2
Details
Lead Sponsor:
Boston VA Research Institute, Inc.
Collaborators:
Celgene Corporation Edward Hines Jr. VA Hospital Kansas City Veteran Affairs Medical Center Michael Debakey Veterans Affairs Medical Center Michael E. DeBakey VA Medical Center VA Greater Los Angeles Healthcare System VA Pittsburgh Healthcare System