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Pembrolizumab (MK-3475) in MM Patients With Residual Disease

NCT02636010 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-29

No results posted yet for this study

Summary

This is a national, multicenter, open label single-arm, non-comparative study that will determine the efficacy, safety and the changes in selected pharmacodynamics markers of MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a response with a previous treatment but who still display some residual disease.

For this purpose, 20 MM patients, who have received any treatment of limited duration either at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks for 1 year, with a potential expansion of 1 additional year of treatment in case of clinical benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be evaluated to understand the role of this monoclonal antibody in this setting.

Conditions

Interventions

DRUG

Pembrolizumab

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Adknoma Health Research

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-07-31
Completion
2020-02-20

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 NCT02636010 on ClinicalTrials.gov