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Third-line Therapy of Multiple Myeloma a Prospective Phase I /II Trial

NCT01010243 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-05-30

No results posted yet for this study

Summary

To investigate the effect of an anti-inflammatory therapy consisting of lenalidomide in combination with pioglitazone, dexamethasone and metronomic low-dose chemotherapy with treosulfan on the response rate in patients with relapsed or refractory or progressive multiple myeloma(MM).

Phase I: to determine the lenalidomide dse for the phase II part (5 mg or 10 mg or 15 mg) on the basis of dose-limiting toxicities (DLTs') in the first 4 weeks of treatment.

Phase II: to determine

* response rate (primary objective)
* time to progression (TTP)
* time to partial response (TPR)
* overall survival (OS)
* quality of life
* tolerability and safety

Conditions

Interventions

DRUG

Lenalidomide, Pioglitazone, dexamethasone, treosulfan

Phase I:lenalidomide dose ( 5 mg or 10 mg or 15 mg) will be determined for phase II on the basis of DLTs in the first 4 weeks for the phase II part. Start Phase I part: lenalidomide 10 mg p.o. daily + pioglitazone 60 mg p.o. daily + treosulfan 250 mg p.o. bid + dexamethasone initially 40 mg p.o. d1-4 and d15-18, then 20mg d1 and d15. dexamethasone 1 mg p.o. continuously within the intervals of pulsed dexamethasone therapy

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Albrecht Reichle, Professor · University of Regensburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-10-31
Completion
2016-10-31

Countries

  • Germany

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 NCT01010243 on ClinicalTrials.gov