This is an open-label, non-randomized Phase 1 study evaluating the role of two regimens:
A) Nivolumab in combination with Pomalidomide and low dose dexamethasone and B) Nivolumab +
Elotuzumab + Pomalidomide + dexamethasone in the treatment of relapse or refractory multiple
The study will be performed in 10 sites in Spain. First, the MTD for the Nivo-Pom-Dex
combination will be determined using a 3+3 scheme. Once the MTD has been determined both
Regimes (A and B) will be open for full accrual and patients will be included in an
alternating way in both regimes simultaneously. In the case that an unacceptable toxicity was
seen in the Lead-in phase (Nivolumab + Pomalidomide + low dose dexamethasone), the other
phase would not be open.
A safety analysis by an internal review committee will be performed once the first six
patients included in the regimen B have completed the first two cycles.
The main purpose of the study is to analyze the proportion of subjects, with refractory or
relapsed multiple myeloma, receiving the combination Nivo-Pom-dex or Nivo-Pom-dex-Elo
experience one or more haematological and non haematological SAE (grade 3 or higher).
The combination of nivolumab with pomalidomide and dexamethasone will demonstrate adequate
safety and tolerability to permit further testing of these combinations in subjects with
multiple myeloma. The addition of elotuzumab to nivolumab, pomalidomide and dexamethasone
will not change the safety profile.
Duration of Study:
The study will remain open for enrolment for 15 months (estimated), or until the planned
total number of 40 subjects is reached if this happens first.
The follow-up of the last recruited patient will be up to 3 years, being the Final analyses
performed 1,5 years after the last patient is included.
Male and female adult patients with Multiple Myeloma in first or subsequent relapses,
previously exposed to both a proteasome inhibitor and a IMID (Lenalidomide). Patients may be
exposed, relapsed or refractory to Lenalidomide.