Clinical trial NCT03168100 (phase 2, status: withdrawn)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: elotuzumab, lenalidomide, dexamethasone, bortezomib
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    no study population. no subjects enrolled.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age and not older than 75 years of age at the
             time of enrollment.

          -  Patients must have completed a stem cell transplant regimen for newly diagnosed
             multiple myeloma (MM) consisting of (at least) induction chemotherapy and single or
             tandem autologous stem cell transplant (ASCT) within eight months of study enrollment.
             The completed regimen may have included post-transplant consolidation therapy, but
             post-transplant consolidation is not required.

          -  Patients must have achieved at least a partial response (PR) (according to
             International Myeloma Working Group (IMWG) criteria) in response to the completed
             transplant regimen.

          -  ECOG ≤ 2 (ECOG of 3 allowed if solely due to symptoms of MM-related bone disease).

          -  Patients must have absolute neutrophil count (ANC) ≥ 1,000/mm3 and a platelet count of
             ≥ 75,000/μL.

          -  Patients must have a baseline serum creatinine level of < 3 mg/dL and baseline alanine
             aminotransferase (ALT) < 3x Upper limit of normal (ULN)

          -  Toxicities related to prior therapies must be resolved to ≤ Grade 2 according to NCI
             Common Terminology for Adverse Events (CTCAE) Version 4.

          -  Female patients must be:

               -  Postmenopausal for at least 1 year before the screening visit, OR

               -  Surgically sterile, OR

               -  If they are of childbearing potential, agree to practice 2 simultaneous effective
                  methods of contraception, from the time of signing the informed consent form
                  through 90 days after the last dose of study drug, OR

               -  Agree to practice true abstinence when this is in line with the preferred and
                  usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,
                  symptothermal, post-ovulation methods] and withdrawal are not acceptable methods
                  of contraception.)

          -  Male patients, even if surgically sterilized (ie, post-vasectomy) must agree to one of
             the following:

               -  Practice effective barrier contraception during the entire study treatment period
                  and through 90 days after the last dose of study drug, OR

               -  Practice true abstinence when this is in line with the preferred and usual
                  lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,
                  symptothermal, post-ovulation methods] and withdrawal are not acceptable methods
                  of contraception.)

          -  Patients must sign an Institutional Review Board (IRB)-approved informed consent
             indicating their understanding of the proposed treatment and understanding that the
             protocol has been approved by the IRB.

        Exclusion Criteria:

          -  Female patients who are nursing or pregnant may not participate. Women of childbearing
             potential must have a negative pregnancy documented within one week of beginning study
             treatment. Refer to the Revlimid Risk Evaluation and Mitigation Strategies (REMS)
             program for more information.

          -  History of poorly controlled hypertension, diabetes mellitus, active or uncontrolled
             hepatitis, or other serious medical or psychiatric illness that could potentially
             interfere with the completion of treatment according to this protocol, or that in the
             opinion of the investigator would constitute a hazard for participating in this study.

          -  History of clinically significant cardiac disease as determined by the enrolling
             physician including cardiac amyloidosis.

          -  Prior malignancy, except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, or other cancer for which the patient has not
             received treatment for one year prior to enrollment. Other cancers will be acceptable
             if the patient's life expectancy exceeds five years.

          -  Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human
             proteins or any of the study medications, their analogues, or excipients in the
             various formulations of any agent (refer to the latest versions of the package
             inserts).