Phase 2
Completed N=33
Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma
Source: ClinicalTrials.gov NCT01380106 ↗Enrolled (actual)
33
Serious AEs
66.7%
Results posted
Jan 2021
Primary outcomePrimary: Serious Adverse Events — 23; 23; 4; 1 Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
23; 23; 4; 1; 1; 0 | — |
| PRIMARY Duration Until Best Response (at Least MR or Minimal Response) |
280.4; 145.5 | — |
Eligibility Criteria
Inclusion Criteria
- Previously diagnosed with multiple myeloma.
- Must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
- Patients may have received lenalidomide and/or dexamethasone
- Patients must have measurable disease:
- Serum monoclonal protein >0.5g/dL and/or 0.2g/24hr urine light chain excretion
- Patients with lower M-protein values or non-secretory myeloma will be eligible if measurable disease can be established, such as serum FreeliteTM chain ratio >5x ULN, measurable soft tissue plasmacytoma >2cm by either physical exam and/or applicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >30%
- Age >=18 years at the time of consent.
- All necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.
- Pre-study ECOG performance status 0-2. Patients with lower performance status based solely on bone pain will be eligible.
- Adequate liver functions: AST and ALT = =3. Patients with painful grade 2 neuropathy are also excluded
- Has platelet count <75x10^9/L within 14 days before enrollment.
- Plasma cell leukemia at time of study entry.
Data sourced from ClinicalTrials.gov (NCT01380106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.