Phase 2
N=64
Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma
Recurrent Plasma Cell Myeloma · Refractory Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00966693 ↗Enrolled (actual)
64
Serious AEs
12.5%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) — 1; 0; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug); Lenalidomide (Drug); Thalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) |
1; 0; 3; 0 | — |
| PRIMARY Complete Response(CR) and Very Good Partial Response(VGPR) |
2; 0; 2; 13; 0; 2 | — |
| SECONDARY Time to Progression |
32.74; 9.04; 14.61; 10.02 | — |
| SECONDARY Progression Free Survival |
32.74; 9.04; 14.61; 10.02 | — |
| SECONDARY Time to Best Response |
19; 5; 5.16; 3.3 | — |
| SECONDARY Incidence of Adverse Events |
0; 0; 2; 10 | — |
| SECONDARY Time to Next Therapy |
52.4; 14.3; 10.5; 6.47 | — |
Summary
This phase I/II trial studies the best dose and side effects of lenalidomide and thalidomide, and how well they work with dexamethasone in treating participants with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, thalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Eligibility Criteria
Inclusion Criteria
- Understand and voluntarily sign an informed consent form
- Relapsed/refractory multiple myeloma (MM) with measurable levels of myeloma paraprotein in serum (>= 0.5 g/dl), urine (>= 0.2 g excreted in a 24-hour collection sample), or abnormal free light chain (FLC) ratio
- Serum creatinine = 1000 cells/mm^3
- Platelet count > 50, 000 cells/mm^3 for patients with 25,000 cells/mm^3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells
- Total bilirubin =< 2.0 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 x upper limit of normal (ULN)
- Able to take prophylactic anticoagulation, warfarin or equivalent agent
- Patient is able to understand and comply with the terms and conditions of the lenalidomide and thalidomide counseling program
- All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist, AND the S.T.E.P.S. program
Exclusion Criteria
- Any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
- Use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy (radiation therapy allowed within 5 days of completion of radiation therapy).
- Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Data sourced from ClinicalTrials.gov (NCT00966693). 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.