SWOG clinical trial number

A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant

Abbreviated Title
Phase III LD vs. VLD for Induction, followed by Transplant in Multiple Myeloma
Status Notes
Revision #24 requires sites to contact all patients that have been enrolled, including those that have completed treatment and follow-up, to offer them participation in extended follow-up.
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates

Research committees



Dexamethasone Filgrastim GM-CSF CC-5013 (Lenalidomide) Bortezomib

Eligibility Criteria Expand/Collapse

Pts must have newly diagnosed multiple myeloma (Section 4.1) with measurable disease within 28 days prior to reg. Pts with non-secretory MM are not eligible unless baseline serum freelite is elevated (must be serum Freelite, not freelight chains). Pts must not have prior chemotherapy or radiotherapy to more than half of pelvis. Prior steroid treatment allowed if it was less than 2 wks duration. No prior bortezomib or lenalidomide treatment allowed. Pts must be at least 18 yrs of age. Pts must have Zubrod PS 0-3. Pts must have adequate marrow function (Section 5.5). Pts must be offered participation in Myeloma Specimen Repository. Pts must have baseline skeletal survey. Institutions must submit local cytogenetics analysis and FISH report. Pts must be offered participation in GEP studies. Pts must be treated for pathologic fractures, pneumonia or symptomatic hyperviscosity prior to reg if present at diagnosis. Pts must have creatinine clearance > 30 cc/min within 28 days prior to reg. Pts must not have uncontrolled, active infection requiring IV antibiotics, NYHA Class III or IV heart failure, myocardial infarction within the last 6 months, history of treatment for clinically significant ventricular cardiac arrhythmias, poorly controlled hypertension or poorly controlled diabetes mellitus. Pts must undergo EKG within 28 days prior to reg. Patients must have negative Hep B, Hep C and HIV test within 28 days prior to reg. Treatment-sensitive HIV infection pts will be eligible if immunological and virologic indices are indicative of favorable long-term survival on basis of HIV infection and life expectancy is limited by MM, not HIV. Pts must not have history of cerebral vascular accident with persistent neurologic deficits. Pts must be able to take aspirin 325 mg daily (or enoxaparin 40 mg SQ daily), unless on anticoagulation therapy such as coumadin or heparin (as these pts will not receive aspirin). Females of childbearing potential must have negative serum or urine pregnancy test with sensitivity of at least 25 mIU/mL 10-14 days prior to and again within 24 hours prior to starting lenalidomide; must agree to abstinence from heterosexual intercourse or begin two acceptable methods of birth control at least 4 weeks before starting lenalidomide. Men must agree not to father a child and to use a condom if he or partner is of child bearing potential. Pts must be counseled a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Pts must not have prior malignancy except 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 yrs.

Publication Information Expand/Collapse


Adjusted indirect treatment comparison of progression-free survival (PFS) associated with DRd and VRd based on MAIA and SWOG S0777 individual patient-level data

B Durie;S Kumar;E Ammann;A Fu;S Kaila;A Lam;S Usmani;T Facon J Clin Oncol 41, 2023 (suppl 16; abstr 8037); ASCO Annual Meeting (June 2-6, 2023, Chicago, IL), poster

Adjusted Indirect Treatment Comparison of Progression-Free Survival Associated With D-Rd and VRd Based on MAIA and SWOG S0777 Individual Patient-Level Data

B Durie;S Kumar;E Ammann;A Fu;S Kaila;A Lam;S Usmani;T Facon Proceedings Society of Hematologic Oncology 2023 Annual Meeting; Lymphoma, Myeloma & Leukemia Vol 23 Suppl 1S1-S593, poster

Impact of Dexamethasone (Dex) Dose Strength on Outcomes in Newly Diagnosed Multiple Myeloma (NDMM): A Secondary Analysis of SWOG Studies S0777 and S1211

R Banerjee;R Sexton;A Cowan;S Ailawadhi;V Rajkumar;S Kunnathu Kumar;S Lonial;B Barlogie;BGM Durie;S Usmani;A Hoering;R Orlowski ASH Annual Meeting (Dec9-12,2023, San Diego, CA), oral


Restricted survival benefit with right-censored data

S Zhang;M LeBlanc;Y Zhao Biometrical Journal Apr;64(4):696-713

PMid: PMID34970772 | PMC number: PMC9162957

Post-Hoc Analysis of Efficacy and Safety in the SWOG S0777 Trial Stratified By Age

B Durie;A Lam;M Ngo;H Pei;E Ammann Blood. 2022;140 (supplement 1):10009-10010; ASH Annual Meeting (Dec 10-12, 2022, New Orleans, LA)


Longer Term Follow-up of the Randomized Phase III Trial SWOG S0777: Bortezomib, Lenalidomide and Dexamethasone Vs. Lenalidomide and Dexamethasone in Patients (Pts) with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant (ASCT)

BGM Durie;A Hoering;R Sexton;M Abidi;J Epstein;V Rajkumar;A Dispenzieri;M Thakuri;F Reu;CM Reynolds;RZ Orlowski;B Barlogie Blood Cancer Journal May 11;10(5):53

PMid: PMID32393732 | PMC number: PMC7214419

Association of Patient Demographic Characteristics and Insurance Status with Survival in Cancer Randomized Clinical Trials with Positive Findings

JM Unger;CD Blanke;M Leblanc;W Barlow;R Vaidya;M Fleury;SD Ramsey;DL Hershman JAMA Network Open Apr 1;3(4):e203842

PMid: PMID32352530 | PMC number: PMC7193331

Developments in continuous therapy and maintenance treatment approaches for patients with newly diagnosed multiple myeloma

M Dimopoulos;A Jakubowiak;P McCarthy;R Orlowski;M Attal;J Blade;H Goldschmidt;K Weisl;K Ramasamy;S Zweegman;A Spencer;J Huang;J Lu;K Sunami;S Lida;W-J Chng;S Holstein;A Rocci;T Skacel;R Labotka;A Palumbo;K Anderson Blood Cancer Journal Feb 13;10(2):17

PMid: PMID32054831 | PMC number: PMC7018731


Bortezomib, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Patients (Pts) with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant (ASCT): Results of the Randomized Phase III Trial SWOG S0777 with Long-Term Follow Up

BGM Durie;A Hoering;R Sexton;M Abidi;J Epstein;SV Rajkumar;A Dispenzieri;S Kahanic;M Thakuri;F Reu;CR Reynolds;RZ Orlowski;B Barlogie Blood 132:1992; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), poster


Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without Intent for immediate autologous stem-cell transplant (SWOG S0777): a randomized, open label, phase 3 trial

B Durie;A Hoering;M Abidi;S Rajkumar;J Epstein;S Kahanic;M Thakuri;F Reu;C Reynolds;R Sexton;R Orlowski;B Barlogie;A Dospenzieri Lancet Feb 4;389(10068):519-527. Epub 2016 Dec 23.

PMid: PMID28017406 | PMC number: PMC5546834

History of diabetes and outcome among participants 65 or older in SWOG clinical trials

DL Hershman;C Till;JD Wright;S Ramsey;W Barlow;J Unger JCO Clinical Cancer Informatics Nov;1:1-12; DOI: https://doi.org/10.1200/CCI.17.00040 Publishedonlineonascopubs.org/journal/ccion November 20, 2017.

PMid: PMID30657402 | PMC number: PMC6640843

The impact of positive SWOG treatment trials on population survival

J Unger;M LeBlanc;C Blanke J Clin Oncol 35, 2017 (suppl; abstr 6513); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster discussion

Proteasome inhibitors in cancer therapy [Review]

E Manasanch;R Orlowski Nature Reviews Clinical Oncology Jul;14(7):417-433, 2017

PMid: PMID28117417 | PMC number: PMC5828026


Bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT): results of the randomized phase III trial SWOG S0777

B Durie;A Hoering;SV Rajkumar;M Abidi;J Epstein;S Kahanic;M Thakuri;F Reu;C Reynolds;R Sexton;R Orlowski;B Barlogie;A Dispenzieri Blood 126(23):25; American Society of Hematology Annual Meeting (Dec 5-8, 2015, Orlando, FL), oral;