Clinical trial NCT02655458 (phase 1, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: elotuzumab, lenalidomide
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject is, in the investigator's opinion, willing and able to comply with the
             protocol requirements.

          -  Subject has given voluntary written informed consent before performance of any
             study-related procedure not part of normal medical care, with the understanding that
             consent may be withdrawn by the subject at any time without prejudice to their future
             medical care.

        Target Population

          -  Subjects with symptomatic MM by IMWG criteria who are receiving or have completed
             induction chemotherapy, who have achieved at least a PR on most recent therapy by IMWG
             criteria, and are eligible for auto-SCT for consolidation. A specific induction
             regimen is not dictated for this protocol, however, the induction regimen must not
             have contained melphalan (L-PAM, Alkeran).

          -  Age > 18 years or legal age of consent per local regulations.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

          -  Documented evidence of newly diagnosed, symptomatic MM, by IMWG criteria within one
             year of enrollment

          -  Prior lenalidomide exposure is permitted only if the subject did not discontinue
             lenalidomide due to a related, grade ≥ 3 AE. Age and Reproductive Status

          -  Men and women of childbearing potential (WOCBP) must be using 2 reliable methods of
             contraception to avoid pregnancy throughout the study for a period of at least 30 days
             before and 90 days after the last dose of investigational product in such a manner
             that the risk of pregnancy is minimized. See Section 4.3.3 for the definition of WOCBP
             and also refer to the Revlimid Risk Management Plan guidelines.

          -  WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L
             or equivalent units of HCG). The first should be performed within 10 to 14 days and
             the second within 24 hours prior to the start of the study drug. A prescription for
             lenalidomide for a female of childbearing potential must not be issued by the
             prescriber until negative pregnancy tests have been verified by the prescriber.

          -  Women must not be breastfeeding.

          -  Men must agree to use a latex condom and a second form of birth control during sexual
             contact with WOCBP, even if they have had a successful vasectomy, and must agree not
             to donate sperm during study drug therapy and for 90 days after therapy.

          -  Subjects must be willing to refrain from blood donations during study drug therapy and
             for 8 weeks after therapy.

        Exclusion Criteria:

        Target Disease

          -  MGUS, Waldenström's macroglobulinemia, or asymptomatic (smoldering) myeloma.

          -  Active plasma cell leukemia (defined as either 20% of peripheral white blood cells
             comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L).

        Medical History and Concurrent Diseases

          -  All AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National
             Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v.4.0)
             Grade ≤ 2.

          -  POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
             endocrinopathy, monoclonal protein, and skin changes).

          -  Acute renal failure due solely to readily reversible causes such as hypercalcemia,
             hyperuricemia, dehydration, hyperviscosity, or acute tubular necrosis from nephrotoxic
             drugs.

          -  Significant cardiac disease as determined by the investigator including:

               1. Known or suspected cardiac amyloidosis

               2. Congestive heart failure of Class III or IV of the NYHA classification

               3. Uncontrolled angina, hypertension or arrhythmia

               4. Myocardial infarction in the past 6 months

               5. Any uncontrolled or severe cardiovascular disease

          -  Prior cerebrovascular event with persistent neurologic deficit.

          -  Known HIV Infection or active hepatitis A, B or C.

          -  Any medical conditions that, in the investigator's opinion, would impose excessive
             risk to the subject.

        Examples of such conditions include:

        a. Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder b. Any
        altered mental status or any psychiatric condition that would interfere with the
        understanding of the informed consent c. Active infection that requires parenteral
        anti-microbial or anti-parasitic treatment

          -  Prior or concurrent malignancy, except for the following:

               1. Adequately treated basal cell or squamous cell skin cancer;

               2. Or any other cancer from which the subject has been disease-free for > 5 years

          -  Uncontrolled diabetes (defined as Hgb A1C > 8.0%)

          -  Unable to tolerate thromboembolic prophylaxis including, as clinically indicated,
             aspirin, Coumadin (warfarin) or dose adjusted low-molecular weight heparin. Physical
             and Laboratory Test Findings

          -  Corrected serum calcium > 11.5 mg/dl within 2 weeks of enrollment.

          -  Absolute neutrophil count < 1000 cells/mm3. No granulocyte colony stimulating factors
             (G-CSF or GMCSF) allowed within 1 week of enrollment. No pegylated granulocyte colony
             stimulating factors are allowed within 3 weeks of treatment start.

          -  Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at
             most recent measurement before enrollment and must be no more than 14 days before
             enrollment. No transfusions are allowed within 72 hours before qualifying laboratory
             value.

          -  Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement
             before enrollment and must be no more than 14 days before enrollment. No transfusions
             are allowed within 72 hours before qualifying laboratory value.

          -  Total bilirubin > 2X ULN ,or direct bilirubin > 2.0 mg/dL.(except patients with
             Gilbert's syndrome then total bilirubin >2X ULN allowed in the absence of other
             hepatic signs or symptoms)

          -  AST or ALT > 3X ULN.

          -  CrCl < 60 ml/min by Cockcroft-Gault Formula Prior Therapy or Surgery

          -  Major surgery within 3 weeks prior to treatment.

          -  Kyphoplasty or vertebroplasty within 1 week of enrollment.

          -  Prior allogeneic stem cell transplant

          -  Treatment with plasmapheresis within 4 weeks before enrollment.

          -  Prior therapy with elotuzumab or any IMiD (including pomalidomide), except for prior
             thalidomide or lenalidomide (as defined in inclusion criteria).

          -  NSAIDs, IV contrast, aminoglycosides, or other potentially nephrotoxic drugs within 2
             weeks of enrollment.

          -  Steroids within 3 weeks of enrollment, except:

               1. ≤ 10 mg prednisone or equivalent per day

               2. Steroid with little to no systemic absorption (ie, topical or inhaled steroids)
                  Allergies and Adverse Drug Reaction

          -  Known hypersensitivity to lenalidomide, dexamethasone, any excipients in the
             elotuzumab formulation (sodium citrate, citric acid, sucrose and polysorbate 80) or
             recombinant protein.

          -  History of Grade 4 rash associated with thalidomide treatment. Sex and Reproductive
             Status

          -  Women of childbearing potential (WOCBP) who are pregnant or lactating or unwilling to
             use 2 forms of effective birth control.

          -  Men who are fertile and sexually active unwilling to use 2 forms of effective birth
             control if their partners are WOCBP. Other Exclusion Criteria

          -  Prisoners or subjects who are involuntarily incarcerated.

          -  Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical (eg, infectious disease) illness.