Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Inclusion Criteria

• Absolute neutrophil count >= 1500/uL
• Platelet count >= 80,000/uL
• Hemoglobin >= 9.0 g/dL
• Serum total bilirubin = = 50 ml/min
• Diagnosis of symptomatic multiple myeloma (MM)
• Patients should have received single autologous stem cell transplantation 60-120 days prior to enrollment to the trial
• Patients should have received the autologous SCT within 12 months of their diagnosis of myeloma to be eligible for the study
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
• Willingness to return to the Mayo Clinic enrolling institution for follow-up
• Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
• Serum monoclonal protein >= 1.0 g/dL
• >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
• Serum immunoglobulin free light chain (involved free light chain [FLC]) >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
• NOTE: For patients with no relapse prior to transplant, measurable disease at the time of diagnosis
• NOTE: For patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant; NOTE: if the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
• Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to initiate prophylaxis with low molecular weight heparin
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and LDE225 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 effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide and LDE225; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP 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; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or 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)
• Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 4 weeks after stopping treatment
• Patient enrolling to this study must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (REMS [TM]) program, and be willing and able to comply with the requirements of (REVLIMID REMS [TM])
• Patients must be willing to provide biological samples as required by the study

Exclusion Criteria

• Prior allogeneic bone marrow/peripheral blood stem cell transplant
• Patients with evidence of disease progression post SCT at the time of consideration for the study enrollment will not be included
• Impaired cardiac function or clinically significant heart disease, including any one of the following:
• Angina pectoris within 3 months
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