Overview

Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
Summary
This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Università Politecnica delle Marche
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Interferon-alpha
Interferons
Liposomal doxorubicin
Thalidomide
Criteria
Inclusion Criteria:

- patients with newly diagnosed or advanced multiple myeloma achieving at least a
minimal response after induction with ThaDD regimen

- Written consent

Exclusion Criteria:

- peripheral neuropathy >= grade 2

- neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl

- severe depression

- organ disfunction > grade 2