Clinical trial NCT02215980 (phase 3, status: active, not recruiting)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: lenalidomide, dexamethasone
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
Eligibility criteria:

        Inclusion Criteria:

          -  Patients >65 years unfit and unsuitable, according to the investigator's opinion, to
             receive approved first line treatments for newly diagnosed MM.

          -  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 not 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             consent may be withdrawn by the patient at any time without prejudice to their future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.

          -  Symptomatic MM based on standard CRAB criteria (5).

          -  Patient has measurable disease, defined as follows: any quantifiable serum monoclonal
             protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where
             applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo
             or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as
             determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an
             abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of
             patients admitted to this study will be oligo- or non-secretory MM with free light
             chains only in order to maximize interpretation of benefit results.

          -  All randomized patients will be selected based on the use of 3 geriatric scales: IADL,
             ADL, Charlson. Unfit patients with clinical sign of frailty (mild, moderate or severe
             frailty), including need help for household tasks and personal care can be enrolled in
             this trial (2,4).

          -  In order to include patients who normally are not select for clinical trials, also
             patients with the following abnormal laboratory values can be considered:

               1. absolute neutrophil count (ANC) < 1 x 10^9/L

               2. platelet count < 80 x 10^9/L

               3. haemoglobin < 8 g/dl.

               4. aspartate transaminase (AST): < 5 x the upper limit of normal (ULN).

               5. alanine transaminase (ALT): < 5 x the ULN.

               6. total bilirubin: > 1.5 x the ULN

               7. calculated or measured creatinine clearance: <30 mL/minute

        The geriatric assessment evaluations will select unfit patients to be randomized regardless
        of possible abnormal laboratory values at the study entry.

        Exclusion Criteria:

          -  Pregnant or lactating females.

          -  Male patients not agreeing to use an acceptable method for contraception (i.e., condom
             or abstinence) for the duration of the study.

          -  Females of childbearing potential not agreeing to use two acceptable methods for
             contraception (e.g. a hormonal contraceptive, intrauterine device, diaphragm with
             spermicide, condom with spermicide, or abstinence) for the duration of the study.

          -  Previous treatment with anti-myeloma therapy (does not include radiotherapy,
             bisphosphonates, or a single short course of steroid < to the equivalent of
             dexamethasone 40 mg/day for 4 days).

          -  Any significant medical disease or conditions that, in the investigator's opinion, may
             interfere with protocol adherence or subject's ability to give informed consent or
             could place the subject at unacceptable risk.

          -  Presence of clinical active infectious hepatitis type B or C, classified into
             Child-Pugh class C (see Appendix V) and HIV.

          -  Presence of acute active infection requiring antibiotics or infiltrative pulmonary
             disease.

          -  Contraindication to any of the required drugs or supportive treatments.

          -  Presence of prior history of malignancies, other than multiple myeloma, with a life
             expectancy < 2 years.

          -  Known allergy to any of the study medications, their analogues, or excipients in the
             various formulations.