Nivolumab Role in the Treatment of Patients With Refractory or Relapse Multiple Myeloma

Sponsor
PETHEMA Foundation
Study ID
NCT03023527
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
  • Pomalidomide — DRUG
  • Dexamethasone — DRUG
  • Elotuzumab — DRUG

Study Details

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 myeloma patients. 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). Additionally, other Research Hypothesis: 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. Study Population: 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.

Key Dates

Start date
Jan 31, 2017
Status verified
May 2018
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: nivo-pom-dex
    Nivolumab in combination with Pomalidomide and low dose dexamethasone
  • Experimental: nivo-pom-dex-elo
    Pomalidomide in combination with Nivolumab , dexamethasone and elotuzumab

Primary Outcome Measure

Safety of Nivolumab: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 month ]

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