Phase I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of thalidomide, lenalidomide, and dexamethasone that can be given to patients with relapsed or refractory MM. The goal of the Phase II portion of this study is to learn if the drug combination can help to control the disease. The safety of the drug combination will be studied in both phases.
Disease Group: Myeloma
Treatment Agent: Dexamethasone
Treatment Location: Only at MDACC
Estimatated Length of Stay in Houston: none
Sponsor: Celgene Corporation
Return Visit: During Cycle 1 patients will return to clinic weekly and all other cycles patients will return monthly.
Home Care: No home care required.
Phase 1: Primary Objectives 1. To determine the maximum tolerated dose (MTD) of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM). Secondary Objectives 1. To determine the Overall response rate (ORR) 2. To determine the Time to progression (TTP) 3. To determine the Progression free survival (PFS) 4. To determine the Time to best response Phase 2: Primary objective: 1. To determine the overall (complete remission (CR) + very good partial response (VGPR)+ partial response (PR)) response rate of the combination after 4 cycles of therapy. Secondary Objectives 1. To determine the CR, VGPR 2. To determine the Time to progression (TTP) 3. To determine the Progression free survival (PFS) 4. To determine the Time to best response 5. To assess the safety of the combination of LTD in patients with RRMM. 6. Time to next therapy 7. Symptom measurement - Multiple-symptom assessment tool
IRB Review and Approval Date: 05/14/2009
Recruitment Status: Closed
Projected Accrual: N/A
1) Understand and voluntarily sign an informed consent form.
2) Age >/= 18 years at the time of signing the informed consent form.
3) Relapsed/refractory MMM 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.
4) Serum Creatnine </= 2.5 mg/dl
5) Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional affective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
6) Continuation from Inclusion # 6: FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
7) Continuation from Inclusion # 7: * A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
8) Laboratory test results within these ranges: Absolute neutrophil count > 1000 cells/mm^3 Platelet count > 50,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells and platelet count > 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 AST (SGOT) and ALT (AGPT) < 3 x ULN
9) Able to take prophylactic anticoagulation, warfarin or equivalent agent
10) Patient is able to understand and comply with the terms and conditions of the Lenalidomide and Thalidomide Counseling Program
11) 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.
1) Any serious medical condition, or psychiatric illness that would
prevent the subject from signing the informed consent form
2) Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
3) 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).
4) Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.
5) The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.