Clinical trial NCT00205751: Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
Official title: International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
first line treatment
thalidomide
melphalan
Lead sponsor: Austrian Forum Against Cancer
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 350
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.


Eligibility criteria: Inclusion Criteria:

* Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
* WHO performance status 0,1,2,or 3
* No prior treatment of multiple myeloma
* Clear requirement of treatment (usually Durie/Salmon stage II or III)
* Anticipated life expectancy of at least 3 months
* Adequate organ function
* Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
* Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
* Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent

Exclusion Criteria:

* Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
* Benign monoclonal gammopathy
* Multiple myeloma of IgM without osteolytic bone lesions
* Smouldering myeloma
* More than 3 irradiation fields
* Irreversible performance status of WHO4
* Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
* Women of childbearing potential
* Preexisting peripheral polyneuropathy
* Congestive heart failure NYHA III, IV
* Acute infection requiring systemic antibiotics at study entry until resolved
* Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
* Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years

Primary outcomes:
measure: Time to progression
measure: Response rate
Secondary outcomes:
measure: Survival
measure: Time to response
measure: Toxicity
measure: Quality of life
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminenspital, 1st Medical Department-center for oncology and hematology
Study officials:
affiliation: Wilhelminenspital 1st medical dep.-center for oncology and hematology
name: Heinz Ludwig, MD,Univ.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ludwig H, Adam Z, Tothova E, Hajek R, Labar B, Egyed M, Spicka I, Gisslinger H, Drach J, Kuhn I, Hinke A, Zojer N. Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma. Haematologica. 2010 Sep;95(9):1548-54. doi: 10.3324/haematol.2009.020586. Epub 2010 Apr 23.
citation: Ludwig H, Hajek R, Tothova E, Drach J, Adam Z, Labar B, Egyed M, Spicka I, Gisslinger H, Greil R, Kuhn I, Zojer N, Hinke A. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood. 2009 Apr 9;113(15):3435-42. doi: 10.1182/blood-2008-07-169565. Epub 2008 Oct 27.