Clinical trial NCT03023527 (phase 1, status: terminated)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: nivolumab, pomalidomide, dexamethasone, elotuzumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, 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
Reason stopped: 
    safety
  
Eligibility criteria:

        Inclusion Criteria:

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

          -  Patient has given voluntary written informed consent before performance of any
             study-related procedure nor part of normal medical care, with the understanding that
             consent may be withdrawn by the patient at any time without prejudice to their future
             medical care.

          -  Patient must be at least 18 year-old.

          -  Patient must have a confirmed diagnosis of symptomatic multiple myeloma and measurable
             secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine
             monoclonal (light chain) protein ≥ 200 mg/24 h. For patients in whom disease is only
             measurable by serum FLC, the involved FLC should be ≥ 10mg/L (100 mg/dl), with an
             abnormal serum FLC ratio.

          -  Patients must have an ECOG performance status of 0, 1 or 2.

          -  Patient has a multiple myeloma in first or second relapse must be exposed, relapsed or
             refractory to IMiD (Revlimid) are eligible for the study. Induction therapy followed
             by autologous stem cell transplantation and consolidations in considered one regimen.

          -  Patient has the following laboratory values within 14 days before baseline visit (Day
             1 Cycle 1 before study drug administration): Platelet count ≥ 75 x 109/L, Haemoglobin
             ≥ 8.0 g/dl. White blood cell count (WBC) ≥ 2.0 x 109/L, Absolute neutrophil count
             (ANC) ≥ 1.5 x 109/L; lower values (platelets ≥ 30 x 109/L and neutrophil count (ANC) ≥
             0,5 x 109/L may be accepted if clearly due to heavy bone marrow involvement by
             multiple myeloma, more than 50% of plasma cell infiltration). Corrected serum calcium
             < 11.5 mg/dl. Aspartate transaminase (AST) ≤ 3 x upper Total Bilirubin ≤ 1.5 x the
             upper limit of normal (except subjects with Gilbert Syndrome, who can have total
             bilirubin < 3.0 mg/dL) or ≤ 2 x upper limit normal if Lenalidomide is being
             prescribed. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min as
             per Crockoft-Gault formula.

          -  Women of childbearing potential must be practicing a highly effective method of birth
             control consistent with local regulations and with the pomalidomide pregnancy
             prevention plan requirements (see Appendix 5) regarding the use of birth control
             methods for subjects participating in clinical studies: e.g. established use of oral,
             injected or implanted hormonal methods of contraception; placement of an intrauterine
             device or intrauterine system; barrier methods: condom with spermicidal
             foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner
             should be the sole partner for that subject); true abstinence (when this is in line
             with the preferred and usual lifestyle of the subject) during and after the study (6
             months after the last dose of any component of the treatment regimen).

          -  Women of childbearing potential must have two negative pregnancy tests (sensitivity of
             at least 25 mIU/mL) prior to starting study treatment. The first pregnancy test must
             be performed within 10-14 days and 24 hours prior to the start of any study drug.
             Females of childbearing potential with regular or no menstrual cycles must agree to
             have pregnancy tests weekly for the first 28 days of study participation and then
             every 28 days while taking the study drug, at study discontinuation, and at day 28
             following the last dose of treatment.

          -  Females of reproductive potential must commit either to abstain continuously from
             heterosexual sexual intercourse or to use two methods or reliable birth control
             simultaneously.

        Exclusion Criteria:

          -  Subject has received previous treatment with Nivolumab, Elotuzumab or Pomalidomide.

          -  Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined
             significance (MGUS), smoldering multiple myeloma (SMM) or plasma cell leukemia.

          -  Subject has previously received autologous stem cell transplantation within 12 weeks
             before Cycle 1 Day 1, or has received other anti-myeloma treatment within 2 weeks
             before Cycle 1 Day 1 (with the exception of an emergency use of a short course of
             corticosteroids (maximum 4 days).

          -  Subject who had previously received allogeneic stem cell transplantation.

          -  Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by
             the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE)
             Version 4.

          -  Prior history of malignancies, other than MM, unless the subject has been free of the
             disease for ≥ 5 years. Exceptions include: Basal or squamous cell carcinoma of the
             skin, Carcinoma in situ of the cervix or breast, incidental histological finding of
             prostate cancer (TNM stage of T1a or T1b).

          -  Hypersensitivity to Pomalidomide or Dexamethasone.

          -  Subjects with any one of the following: congestive heart failure (NYHA class III or
             IV), myocardial infarction within 2 months prior to starting the study treatment,
             unstable or poorly controlled angina pectoris (including Prinzmetal variant angina
             pectoris), known or suspected amyloidosis or arrhythmia.

          -  Has an active autoimmune disease or a documented history of autoimmune disease, or a
             syndrome that requires systemic steroids or immunosuppressive agents. Subjects with
             vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone
             replacement, psoriasis not requiring systemic treatment or resolved childhood
             asthma/atopy would be an exception to this rule. Subjects that require intermittent
             use of bronchodilators or local steroid injections would not be excluded from the
             study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's
             syndrome will not be excluded from the trial.

          -  Has a diagnosis of immunosuppressive disorder or is on any other form of
             immunosuppressive therapy within 7 days prior to the first dose of trial treatment.

          -  Subject has had radiation therapy within 28 days of Cycle 1 Day 1, except for a
             localized plasmacytoma, that is not the only evidence of the disease.

          -  Subject has meningeal involvement of multiple myeloma.

          -  Subjects unable or unwilling to undergone antithrombotic prophylactic treatment.

          -  Pregnant or breastfeeding females.

          -  Known human immunodeficiency virus (HIV) positivity, active infectious hepatitis A, B
             or C or chronic hepatitis B or C, or any other active infection..

          -  Incidence of gastrointestinal disease that may significantly alter the absorption of
             Pomalidomide.

          -  Subject who received any of the following within the last 21 days of initiation of
             study treatment: major surgery (except kyphoplasty) or use of any anti-myeloma drug
             therapy