Phase
Condition
Bone Diseases
Cancer/tumors
Cancer
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 and ≤ 75
Histologic and serologic findings from MSKCC confirming the diagnosis of multiplemyeloma. Standard diagnostic criteria for multiple myeloma will be used, as per therevised International Myeloma Working Group diagnostic criteria.
Patients must have symptomatic multiple myeloma without advanced organ damage (such asmultiple fractures or advanced bone disease causing immobilization, renal failure,spinal cord compression, or organ compromise due to soft tissue plasmacytoma). Ifimmediate therapy with radiation and high-dose steroids (eg, for cord compression) orwith bortezomib-based therapy (eg, for renal failure) is required, the patient is noteligible for this trial.
Patients may have received 1 cycle of prior therapy with dexamethasone for multiplemyeloma.
Adequate organ function is required, defined as follows:
ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due tomultiple myeloma)
Serum bilirubin ≤ 2.0 mg/dl
AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal
Adequate renal function as assessed by calculated creatinine using Cockcroft-Gaultestimation of CrCl (see Appendix I): Subjects must have calculated creatinineclearance ≥ 30ml/min by Cockcroft-Gault formula
Performance status (ECOG) ≤ 2 (Appendix E).
Eligible for SCT with LVEF ≥ 50% by MUGA or ECHO, and diffusing capacity > 50%predicted by pulmonary function testing
Ability to understand the investigational nature of this study and to give informedconsent
All study participants must be registered into the mandatory Revlimid REMS® program,and be willing and able to comply with the requirements the of Revlimid REMS® program
Females of childbearing potential (FCBP)† must have a negative serum or urinepregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior toand again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptionsmust be filled within 7 days) and must either commit to continued abstinence fromheterosexual intercourse or begin TWO acceptable methods of birth control, one highlyeffective method and one additional effective method AT THE SAME TIME, at least 28days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancytesting. Men must agree not to father a child and agree to use a latex condom duringsexual contact with females of child bearing potential even if they have had asuccessful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy TestingGuidelines and Acceptable Birth Control Methods.
Able to take aspirin 325mg or 81mg daily as prophylactic anticoagulation (patientsintolerant to ASA may use Coumadin or low molecular weight heparin).
Exclusion
Exclusion Criteria:
Prior treatment for myeloma except for one cycle of dexamethasone
History of thromboembolic disease within the past 6 months regardless ofanticoagulation
Myocardial infarction within 6 months prior to enrollment, or New York HospitalAssociation (NYHA) Class III or IV heart failure (see APPENDIX F), uncontrolledangina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence ofacute ischemia or active conduction system abnormalities.
Pregnant or breast-feeding women are excluded due to the potential teratogenicity oflenalidomide.
Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insituof the cervix, or presence of myelodysplastic or myeloproliferative disease. Patientswith prior malignancies with a disease-free interval of ≥ 5 years are eligible.
Patients who have had prior malignancies within the past 5 years but are considered tobe "cured" with a low likelihood of recurrence may be eligible at the discretion ofthe Principal Investigator.
Active hepatitis B or C infection
HIV 1 or 2 positivity
Any other medical condition or laboratory evaluation that, in the treating physician'sor principal investigator's opinion, makes the patient unsuitable to participate inthis clinical trial
Study Design
Connect with a study center
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York 11725
United StatesSite Not Available
Memorial Sloan Kettering West Harrison
Harrison, New York 10604
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
United StatesSite Not Available
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York 10591
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York 10591
United StatesSite Not Available
Memorial Sloan Kettering West Harrison
West Harrison, New York 10604
United StatesSite Not Available

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