SWOG clinical trial number
S0204

A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Newly Diagnosed Multiple Myeloma Tandem Transplant
Activated
06/15/2002
Closed
10/15/2005
Participants
NCORP, Limited Institutions: BMT Members, Members, Medical Oncologists, Pathologists

Research committees

Myeloma

Treatment

Cyclophosphamide Prednisone Dexamethasone Filgrastim GM-CSF Melphalan Thalidomide

Eligibility Criteria Expand/Collapse

Pts must have newly diagnosed active multiple myeloma requiring treatment (Durie-Salmon Stage >/= 1) as outlined in the protocol. Pts with IgM peaks are not eligible unless there is either > 30% bone marrow plasmacytosis or > 3 lytic lesions on skeletal survey. All necessary baseline studies for determining stage, blood work and bone marrow must be obtained within 28 days prior to registration. Pts must have received no prior chemotherapy for this disease. Pts may have received up to, but not more than, 8 weeks of prior thalidomide therapy. Pts must have received no prior radiotherapy to a large area of the pelvis. Prior steroid treatment is allowed provided treatment was not more than 2 weeks. Pts must be >/= 18 and < 66 years of age. Zubrod PS of 0-2. Pts with poor PS (3-4), based solely on bone pain, are eligible. Pretreatment pathology materials must be submitted as outlined in the protocol. Institutions must have IRB approval of S0309. Pts must be offered participation in S0309. Pts with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity must have these conditions attended to prior to registration. Pts must have adequate renal, liver, cardiac, and pulmonary function as outlined in the protocol. Pts must not be Hepatitis B or HIV positive. Pts must have a negative Hepatitis B and HIV test performed within 28 days prior to registration. Pts must not have a history of chronic cerebral vascular accident. Pts must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method. Pts must be fully aware of the teratogenic potential of thalidomide and agree to fully comply with the guidelines regarding contraception. Pts must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program. Women of childbearing potential must have a negative pregnancy test performed within 24 hours prior to beginning therapy. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the pt has been disease-free for five years.

Publication Information Expand/Collapse

2018

Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials

S Ailawadhi;S Jacobus;R Sexton;A Stewart;A Dispenzieri;M Hussein;JA Zonder;J Crowley;A Hoering;B Barlogie;R Orlowski;S Rajkumar Blood Cancer Journal, Jul 6;8(7):67

PMid: PMID29980678 | PMC number: PMC6035273

2016

Disease and outcome disparities in multiple myeloma (MM): exploring the role of race/ethnicity and obesity in Cooperative Group Clinical Trials

S Ailawadhi;S Jacobus;R Sexton;AK Stewart;A Dispenzieri;MA Hussein;J Zonder;J Crowley;A Hoering;B Barlogie;R Orlowski;SV Rajkumar Blood 128:1192; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), oral

2009

Phase II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based autotransplantation thalidomide-prednisone maintenance for untreated multiple myeloma: a Southwest Oncology Group Trial (S0204) [PMID19546405; PMC2717757]

MA Hussein;V Bolejack;JA Zonder;BGM Durie;AJ Jakubowiak;JJ Crowley;B Barlogie Journal of Clinical Oncology 27(21):3510-3517

2008

Prevention of thalidomide- and lenalidomide-associated thrombosis in myeloma [PMID 18094721]

A Palumbo;SV Rajkumar;MA Dimopoulos;PG Richardson;J San Miguel;B Barlogie;J Harousseau;JA Zonder;M Cavo;M Zangari;M Attal;A Belch;S Knop;D Joshua;O Sezer;H Ludwig;D Vesole;J Blade;R Kyle;J Westin;D Weber;S Bringhen;R Niesvizky;A Waage;M von Lilienfeld-Toal;S Lonial;SJ Morgan;RZ Orlowski;K Shimizu;KC Anderson;M Boccadoro;BG Durie;P Sonneveld;MA Hussein Leukemia 22(2):414-423

2006

S0204: melphalan (MEL)-based tandem autotransplants (TAT) for multiple myeloma (MM) with thalidomide/dexamethasone (TD) induction and thalidomide/prednisone (TP) maintenance: a phase II trial of the Southwest Oncology Group

MA Hussein;AJ Jakubowiak;V Bolejack;J Zonder;J Crowley;B Barlogie Blood 108:#3088

2005

SWOG 0204; phase 2 trial of thalidomide (T) + dexamethasone (D) induction followed by tandem autotransplant (TAT) and prednisone (P) + T maintenance for multiple myeloma (MM)

MA Hussein;J McCoy;A Jakubowiak;BG Durie;JJ Crowley;B Barlogie Blood (ASH Annual Meeting Abstracts) 106(11): #1169