SWOG clinical trial number
SWOG-9321

Standard Dose Versus Myeloablative Therapy For Previously Untreated Symptomatic Multiple Myeloma

Closed
Phase
Accrual
90%
Published
Abbreviated Title
Previously Untreated MM
Activated
01/15/1994
Closed
09/15/2000
Participants
NCORP, Limited Institutions: SWOG Approved Autologous BMT Facilities, Members, ECOG, CALGB

Research committees

Myeloma

Treatment

Cyclophosphamide Prednisone BCNU Cyclosporine Filgrastim Intron A Melphalan Mesna Methotrexate VAD

Eligibility Criteria Expand/Collapse

Newly diagnosed active Multiple Myeloma (MM); smoldering myeloma allowed if evidence of progressive disease requiring chemo.; protein criteria must be present; non-secretory patients are eligible if the patient has > or = 30% plasmacytosis; no prior chemo. for myeloma; prior RT for isolated plasmacytomas allowed if cumulative total doses do not exceed limits specified in protocol; patients must < / or = 70 years of age; SWOG PS 0-2 (but PS of 3-4 is allowed if based solely on bone pain); submission of pre-treatment bone marrow aspirate, paraffin block, and serum is mandatory; no significant co-morbid medical conditions, or uncontrolled life-threatening infection or uncontrolled diabetes allowed; patient must have adequate cardiac function, no history of COPD or chronic cerebral vascular accident; patients with renal failure, even if on dialysis, are eligible if it is felt to be due to the myeloma and if duration of renal failure does not exceed 2 months; financial clearance for transplant must be obtained prior to randomization.

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

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

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

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

2013

Modeling the relationship between progression-free survival and overall survival: the phase 2/3 trial

M Redman;B Goldman;M LeBlanc;A Schott;LH Baker Clinical Cancer Research, 19(10):2646-2656;

PMid: PMID23669424 | PMC number: PMC4131693

2011

Prognostic factor analyses of myeloma survival with intergroup trial S9321 (INT 0141): examing whether different variables govern different time segments of survival [PMID21153898;PMC3053415]

B Barlogie;V Bolejack;M Schell;J Crowley Annals of Hematology 90(4):423-428

2010

Long-term follow-up of autotransplantation trials for multiple myeloma: update of protocols conducted by the intergroupe francophone du myelome, southwest oncology group, and university of arkansas for medical sciences [PMC2834471; PMID20085933]

B Barlogie;M Attal;J Crowley;F van Rhee;J Szymonifka;P Moreau;B Durie;J Harosseau Journal of Clinical Oncology 28(7):1209-1214

2009

Long-term follow-up of autotransplant (AT)-supported high-dose melphalan (hdm) for multiple myeloma (MM): update of Intergroup Francophone du Myeloma (IFM), Southwest Oncology Group (SWOG), and Arkansas (ARK) Total Therapy (TT) trials

B Barlogie;M Attal;J Crowley;J Harousseau Journal of Clinical Oncology 27:15s, abst. #8519

Prognostic factor analyses of myeloma (MM) survival outcomes on intergroup trial S9321 (int 0141): examining whether different variables govern different time segments of survival

J Crowley;V Bolejack;K Robert;K Anderson;B Barlogie Journal of Clinical Oncology 27:15s, abst. #8599

Genetic polymorphisms of EPHX1, Gsk3B, TNFSF8 and myeloma cell DKK-1 expression linked to bone disease in myeloma

B Durie;B Van Ness;C Ramos;O Stephens;M Haznadar;A Hoering;J Haessler;M Katz;G Mundy;R Kyle;GA Morgan;J Crowley;B Barlogie;J Shaughnessy Leukemia 23(10):1913-1919

2008

Analytical approaches for the BOAC SNP panel association with progression free survival in myeloma

B Van Ness;C Ramos;VK Kumar;M Steinbach;B Durie;J Crowley;B Barlogie;A Hoering;J Haessler;DC Johnson;G Morgan Blood 112:abst.#2715

Genomic variation in myeloma: design, content, and initial application of the Bank On A Cure SNP Panel to detect associations with progression-free survival [PMID18778477; PMC2553089]

B Van Ness;C Ramos;M Haznadar;A Hoering;J Haessler;J Crowley;S Jacobus;M Oken;V Rajkumar;P Greipp;B Barlogie;B Durie;G Atluri;G Fang;R Gupta;M Steinbach;V Kumar;R Mushlin;D Johnson;G Morgan BMC Medicine 6:26

2006

Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: final results of phase III US Intergroup Trial S9321

B Barlogie;RA Kyle;KC Anderson;PR Greipp;HM Lazarus;DD Hurd;J McCoy;DF Moore Jr;SR Dakhil;KS Lanier;RA Chapman;JN Cromer;SE Salmon;B Durie;JJ Crowley Journal of Clinical Oncology 24(6):929-936

2005

Incidence, outcomes, and SNP genotypes show different ethnic association in patients with myeloma, assessed in SWOG and ECOG clinical trials S9321 and E9486: from the Bank on a Cure

B Van Ness;J Crowley;C Ramos;S Grindle;E Rasmussen;E Blood;A Hoering;B Barlogie;P Greipp;B Durie Blood (ASH Annual Meeting Abstracts) 106(11): #506

SNP genotypes show association with common toxicities during both VAD induction and high dose melphalan with autologous transplant support in Intergroup trial S9321 for myeloma: from the bank on a cure

BG Van Ness;JC Crowley;C Ramon;S Grindle;E Rasmussen;A Hoering;P Greipp;B Barlogie;B Durie Blood (ASH Annual Meeting Abstracts) 106(11): #3488

SNP genotypes as prognostic factors associated with staging in myeloma: the first combined SNP association analysis of SWOG, ECOG, and MRC clinical trials from the Bank on a Cure

B Van Ness;J Crowley;E Blood;E Rasmussen;C Ramos;S Grindle;G Morgan;D Johnson;A Hoering;P Greipp;B Barlogie;B Durie Blood (ASH Annual Meeting Abstracts) 106(11): #3489

2004

Genetic polymorphisms associated with clinical outcome in the Intergroup trial S9321, comparing high dose therapy with standard dose therapy for myelomaon, on behalf of ECOG, SWOG, CALGB, and the bank on a cure

R Santana-Davila;J Crowley;B Durie;B Barlogie;P Greipp;B Van Ness Blood 104(11): #1495

Comparable survival in newly diagnosed multiple myeloma (MM) after VAD induction with high dose therapy using melphalan 140mg/m2 + TBI 12 Gy (MEL + TBI) versus standard therapy with VBMCP and no benefit from interferon (IFN) maintenance: final clinical results of intergroup trial S9321 in the context of IFM 90 and MRC

J Crowley;R Fonseca;P Greipp;J McCoy;B Barlogie Blood 104(11): #539

Extreme regression: a statistical technique for finding good or poor prognostic groups, illustrated using myeloma patient data from Intergroup trial S9321

JJ Crowley;J McCoy;M LeBlanc;B Barlogie Blood 104(11): #5202

2003

Southwest Oncology Group studies in bladder cancer

ED Crawford;DP Wood;DP Petrylak;J Scott;CA Coltman, Jr;D Raghavan Cancer Supplement 97(8):2099-2108

Comparable survival in multiple myeloma (MM) with high dose therapy (HDT) employing MEL 140 mg/m2 + TBI 12 Gy autotransplants versus standrad dose therapy with VBMCP and no benefit from interferon (IFN) maintenance: results of Intergroup trial S9321

B Barlogie;R Kyle;K Anderson;P Greipp;H Lazarus;J Jacobson;E Rasmussen;J Cromer;J Crowley Blood 102(11):(#135)

2002

A simple classification to identify poor-risk untreated myeloma

PR Greipp;S Kumar;EA Blood;M Rue;J Jacobson;TM Therneu;DR Larson;KC Ancerson;MM Oken;RA Kyle Blood 100(11):598a(#2351)

2000

A protocol for triple color interphase FISH on archived bone marrow biopsies from myeloma prepared with precipitating fixatives

E Tian;K Bumm;Y Xiao;H Xu;A Li;E Williamson;B Barlogie;J Sawyer;J Shaughnessy Blood 96(11):155a(#665)

BETA 2 microglobulin (O2M) and plasma cell labeling index (PCLI) constitute a strong prognostic index in the SWOG Intergroup transplant trial S9321: Observations on gender and age

PR Greipp;JL Jacobson;JJ Crowley;KJ Henderson;KC Anderson;RA Kyle;B Barlogie Blood 96(11):152a(#653)

1999

Planned melphalan-total body irradiation (MEL-TBI) - based allogeneic transplantation for multiple myeloma (MM) up t age 55: an intergroup experience (CALGB, ECOG and SWOG) under the auspices of the Southwest Oncology Group (SWOG 9321)

R Desika;S Salmon;K Anderson;R Kyle;J Crowley;B Barlogie Blood 94(10)Suppl.1:346a(#1546)part_1_of_2

The major vault protein (MVP), a new multidrug resistance associated protein, is frequently expressed in multiple myeloma

LM Rimsza;K Campbell;WS Dalton;S Salmon;G Willcox;TM Grogan Leukemia and Lymphoma 34(3-4):315-324