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

NCT03023527 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-05-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Nivolumab

DRUG

Pomalidomide

DRUG

Dexamethasone

DRUG

Elotuzumab

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Adknoma Health Research, S.L.

    collaborator UNKNOWN

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03023527 on ClinicalTrials.gov