Know Cancer

or
forgot password

Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for


Thalidomide has already been used as maintenance and/or consolidation after high-dose
therapy followed by autologous stem cell transplantation. Despite a number of phase II and
III studies the issues of right dose and duration of thalidomide and subsets of patients
benefiting from it have not yet been settled We explored the maintenance therapy after
thalidomide, dexamethasone and pegylated liposomal doxorubicin called ThaDD protocol.
Patients with de novo or relapsed MM obtaining at least minor response after 4 to 6 ThaDD
courses, were randomized to receive standard maintenance therapy with IFN 3 MU 3 times a
week or an experimental maintenance therapy such as thalidomide 100 mg per day until relapse
or intolerable side effects. Both groups also received pulsed dexamethasone 20 mg 4 days a
month.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Offidani Massimo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

clinica di ematologia ospedali riuniti ancona università politecnica delle marche

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

MO 02/02 MM

NCT ID:

NCT00633542

Start Date:

June 2003

Completion Date:

October 2007

Related Keywords:

  • Multiple Myeloma
  • thalidomide
  • maintenance
  • interferon
  • dexamethasone
  • newly diagnosed multiple myeloma
  • relapsed refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location