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Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma

NCT02188537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-06-26

No results posted yet for this study

Summary

Trial objectives:

To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial.

Additional research questions:

To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.

Conditions

Interventions

DRUG

Nelfinavir

Nelfinavir 2x 2500 mg p.o. days 1 - 14

DRUG

bortezomib

Bortezomib 1.3 mg/m2 i.v. or s.c. days 1, 4, 8, 11

DRUG

Dexamethasone

Dexamethasone 20 mg p.o. days 1-2, 4-5, 8-9, 11-12

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Christoph Driessen, Prof MD · Cantonal Hospital of St. Gallen

  • Panagiotis Samaras, MD · Universitätsspital Zürich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-02
Primary Completion
2016-07-26
Completion
2018-04-17

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

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 NCT02188537 on ClinicalTrials.gov