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NOX-A12 in Combination With Bortezomib and Dexamethasone in Relapsed Multiple Myeloma

NCT01521533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-10-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).

Conditions

Interventions

DRUG

NOX-A12

Pilot Group (NOX A12 single agent, and combined with VD): * 3 cohorts of 3 patients will receive treatment with NOX A12 alone at a single dose of 1, 2 or 4 mg/kg i.v. 2 weeks before the combination treatment of NOX A12 and VD will start. The combination of NOX A12 and VD will follow a dose titration design beginning at 1 mg/kg NOX A12 (cycle 1) proceeding to dose levels of 2 mg/kg (cycle 2) and 4 mg/kg (cycle 3) NOX A12 in combination with VD. This is followed by consolidation in cycles 4-8 when NOX-A12 will be kept at the highest individually titrated dose. Expansion Group (NOX A12 in combination with VD): * Expansion patients will not receive single agent NOX-A12, but will receive combination treatment as for the pilot group.

Sponsors & Collaborators

  • TME Pharma AG

    lead INDUSTRY

Principal Investigators

  • Kai Riecke, MD · TME Pharma AG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • Austria
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

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 NCT01521533 on ClinicalTrials.gov