A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

B-cell Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774345
• Other study ID #: CC-5013-CLL-002
• Status: Completed
• Phase: Phase 3
• Start date: January 27, 2009
• Est. completion date: October 27, 2020

Study information

• Verified date: November 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

Description:

This is a phase 3, randomized (computer assigned by chance to treatment arm), study being completed an multiple sites to compare the safety and efficacy (how well a drug works) of lenalidomide maintenance therapy to placebo (dummy capsule that contains no lenalidomide or active substances) maintenance therapy. Patients are assigned by a computer with a 50/50 chance to receive placebo or lenalidomide study treatment. Study drug will be taken once each day until the patient discontinues the study. Patients will remain on study drug until progression of disease. Patients will visit their study doctor every 28 days until disease progression to complete safety and efficacy assessments. Quality of life assessments will be completed every other month. If a patient who discontinue study drug prior to disease progression (i.e. due to an adverse reaction to the study drug), they will continue to visit the study doctor each month to complete the efficacy assessments up to progression of disease. Safety assessments may include laboratory blood tests, ECG tests and questions about any medical conditions or side effects experienced during the study. Efficacy assessments may include laboratory blood tests and focused physical exams. Computed tomography (CT) scans along with blood tests and bone marrow samples will be collected to confirm if a patient has improvement of response while on study. After disease progression, patients will be contacted every 12 weeks for survival information, next CLL treatments and quality of life questions. Subjects currently on lenalidomide treatment will discontinue lenalidomide treatment immediately and complete the Treatment Discontinuation assessment. The subjects will then transition to the survival follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: October 27, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form.

2. Must be greater than or equal to 18 years at the time of signing the informed consent form.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]).

5. Must have been treated with one of the following in first and/or second line:

• a purine analog-containing regimen
• a bendamustine-containing regimen
• an anti-CD20 antibody-containing regimen
• a chlorambucil-containing regimen
• an alemtuzumab-containing regimen (for those subjects with a 17p deletion)

6. Must have achieved a minimum response of partial response (PR, nPR, CRi, CR, and MRD-negative CR) (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia [Hallek, 2008]) following completion of second-line induction therapy prior to randomization (documentation of response status must be available). Second-line induction therapy must be documented to have been of sufficient duration.

7. Must have completed last cycle of second-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.

8. Must have an ECOG performance status score of less than or equal to 2.

9. Females of childbearing potential (FCBP)† must:

• Have two negative medically supervised pregnancy tests prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.
• Either commit to continued abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.

10. Male subjects must:

• Commit to continued abstinence from heterosexual contact or agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
• Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.

11. All subjects must:

• Have an understanding that the study drug could have a potential teratogenic risk.
• Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. • Agree not to share study medication with another person.
• All subjects must be counseled about pregnancy precautions and risks of fetal exposure.

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

2. Active infections requiring systemic antibiotics.

3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy

4. Autologous or allogeneic bone marrow transplant as second-line therapy.

5. Pregnant or lactating females.

6. Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.

7. Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.

8. Known presence of alcohol and/or drug abuse.

9. Central nervous system involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.

10. Prior history of malignancies, other than CLL, unless the subject has been free of the

disease for =5 years. Exceptions include the following:

• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)

11. History of renal failure requiring dialysis.

12. Known Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), and/or active Hepatitis C Virus (HCV) infection.

13. Prior therapy with lenalidomide.

14. Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).

15. Any of the following laboratory abnormalities:

• Calculated (method of Cockroft-Gault) creatinine clearance <60 mL/min.
• Absolute neutrophil count (ANC) <1,000/µL (1.0 X 109/L)
• Platelet count <50,000/µL (50 X 109/L)
• Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
• Serum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)

16. Grade 4 rash due to prior thalidomide treatment

17. Uncontrolled hyperthyroidism or hypothyroidism

18. Venous thromboembolism within one year

19. Greater than or equal to Grade-2 neuropathy

20. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

21. Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)

22. Known allergy to allopurinol for subjects assessed with PR following their second-line induction therapy.

23. Prisoners.

24. More than 2 prior lines of CLL therapy.

Related Conditions & MeSH terms

• B-cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Lenalidomide
Lenalidomide capsules given orally on days 1-28 of a 28 day cycle
• Placebo
Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Locations

Country	Name	City	State
Australia	IMVS	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Concord Hospital	Concord	New South Wales
Australia	Peter MacCallum Cancer Centre	East Melbourne
Australia	Frankston Hospital	Farkston
Australia	St. Vincent Hospital	Fitzroy
Australia	Nepean Hospital	Kingswood, NSW
Australia	Clinical Trials Unit The St George Hospital	Kogarah
Australia	Sir Charles Gairdner Hospital	Nedlands
Australia	Haematology and Oncology Clinics of Australasia	South Brisbane	Queensland
Australia	Royal North Shore HospitalDepartment of HematologyLevel 4	St. Leonards
Australia	The Queen Elizabeth Hospital	Woodville
Austria	Universitaetsklinik Innsbruck	Innsbruck
Austria	Hospital Bamherzige Schwestern	Linz
Austria	Medical University of Vienna Internalmedicine 1, Hematology	Vienna
Belgium	AZ Sint-Jan AV Brugge	Brugge
Belgium	Institut Jules Bordet	Brussels
Belgium	Cliniques Universitaires St Luc	Bruxelles
Belgium	UZ Gent Hematology	Gent
Belgium	Hopital de Jolimont	Haine-Saint Paul
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	CHU Mont -Godinne	Yvoir
Canada	CDHA Centre for Clinical Research	Halifax	Nova Scotia
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	CIUSSS de l'Est-de-l'Ile-de-Montreal	Montreal/Quebec	Quebec
Canada	Hopital De L'Enfant-Jesus	Quebec
Canada	Regional Health Authority B-Saint John Regional Hospital	Saint John	New Brunswick
Canada	General Hospital, Eastern Health	St John's	Newfoundland and Labrador
Canada	Princess Margaret Hospital	Toronto	Ontario
Colombia	Oncomedica S.A.	Monteria
Czechia	Interni hematoonkologicka klinika	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Poliklinika Agel Novy Jicin	Novy Jicin
Czechia	Faculty Hospital Plzen	Plzen
Czechia	Faculty Hospital Kralovske Vinohrady	Prague
Czechia	General Faculty Hosital1.Internal Clinic	Prague
Denmark	Rigshospitalet University Hospital	Copenhagen
Denmark	Odense University Hospital	Odense
Denmark	Vejle Hospital	Vejle
France	Hopital Aviecenne	Bobigny Cedex
France	Bergonie Institut	Bordeaux
France	CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire	Clermont Ferrand
France	CHU Hopital Michallon	Grenoble Cedex 09
France	Centre Hospitalier Lyon Sud	Lyon
France	Cetre Hospitalier Hotel-Dieu	Nantes cedex 01
France	Hopital de l'Archet 1	Nice
France	Hopital Petie- SalpetriereDepartment d'Hematologie	Paris
France	CHU La Miletrie	Poitiers
France	CHU de Reims	Reims cedex
France	CLCC H BecquerelHematology	Rouen
France	Hopital Bretonneau	Tours Cedex
Germany	Charite, Campus Benjamin Franklin, Medizinische Klinik III	Berlin
Germany	Universitaetsklinikum EssenZentrum fuer Innere Medizin	Essen
Germany	Innere Medizin Klinikum Frankfurt Oder GmBH	Frankfurt (Oder)
Germany	Universitaetsklinikum FreiburgInnere Med.1, Haematologie	Freiburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis fuer Haematologie und Onkologie Koblenz	Koblenz
Germany	Klinikum der Universitat zu Koln	Köln
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Mannheimer Onkologie Praxis	Mannheim
Germany	Stadtisches Klinikum Munchen GmbH	München
Germany	TU München - Klinikum rechts der Isar	München
Germany	Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis	Münster
Germany	University Hospital of Ulm	Ulm
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum	Debrecen
Hungary	Petz Aladar Country Hospital	Gyor
Hungary	Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar	Pecs
Hungary	Szegedi TudomanyegyetemII Belgyogyaszati Klinika	Szeged
Hungary	Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza	Tatabanya
Ireland	St James's Hospital	Dublin
Ireland	Midwestern Regional Hospital	Limerick
Israel	Ha'Emek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Center	Beer Sheva
Israel	Bnei Zion Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar-Saba
Israel	Western Galilee Hospital	Naharia
Israel	Rabin Medical Center	Petach Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center Department of Hematology	Tel Aviv
Israel	Sheba Medical Center	Tel Hashomer
Italy	Azienda Ospedaliera Poloclinico di Bari	Bari
Italy	Istituto dei Tumori Giovanni Paolo II di Bari	Bari
Italy	AO Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera Vittorio Emanuele-Ferrarotto	Catania
Italy	A.O. Pugliese Ciaccio	Catanzaro
Italy	Azienda Ospedaliera Annunziala	Cosenza
Italy	Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi	Ferrara
Italy	Azienda Ospedaliera Universitaria Careggi	Florence
Italy	Azienda Ospedaliero Universitaria OORR Foggia	Foggia
Italy	Azienda Ospedaliera San Martino	Genova
Italy	IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena	Milan
Italy	Fondazione Centro San Raffaele del Monte Tabor	Milano
Italy	Istituto Oncologico Europeo	Milano
Italy	Azienda Ospedaliero Universitaria di Modena	Modena
Italy	Ospedale Cardarelli	Naples
Italy	Policlinico Universitario Federico II	Naples
Italy	Universita del Piemonte Orientale	Novara
Italy	Universita degli Studi di Padova	Padova
Italy	Azienda Ospedaliera Ospedale San Carlo	Potenza
Italy	Azienda Policlinico Umberto I, Universita La Sapienzadi Roma	Rome
Italy	Ospedale Sant'Eugenio	Rome
Italy	Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte	Siena
Italy	Osp. S.Giovanni Battista Le Molinette	Torino
Italy	Ospedale Umberto I	Torrette Di Ancona
Italy	Ospedale San Bortolo di Vicenza	Vicenza
Mexico	Instituto Biomedico de Investigacion AC	Aguascalientes
Netherlands	VU University Medical Center	Amsterdam
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Middlemore Clinical Trials	Manukau
New Zealand	North Shore Hospital	Takapuna
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Malopolskie Centrum Medyczne S.C.	Kraków
Poland	Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi	Lodz
Poland	Specjalistyczny Szpital miejski im. Kopernika	Torun
Poland	Centralny Szpital Kliniczny MON	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu	Wroclaw
Portugal	Hospitais da Universidade de Coimbra	Coimbra
Portugal	Hospital de Dia de Hematologia	Lisbon
Portugal	Instituto Portugues Oncologia do Porto Francisco Gentil EPE	Porto
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Spitalul Clinic Coltea	Bucharest
Romania	Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Sibiu	Sibiu
Romania	Spitalul Clinic Municipal de Urgenta Timisoara	Timisoara
Russian Federation	Archangelsk Regional Clinical Hospital	Arkhangelsk
Russian Federation	City Hospital 8	Barnaul
Russian Federation	State Healthcare Institution Sverdlovsk regional clinical hospital 1	Ekaterinburg
Russian Federation	GMU Republic clinical hospital	Kazan
Russian Federation	Krasnoyarsk Regional Clinical Hospital	Krasnoyarsk
Russian Federation	Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl	Moscow
Russian Federation	NUZ Central Clinical Hospital	Moscow
Russian Federation	State Budgetary Institution of the City of Moscow	Moscow
Russian Federation	Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko	Nizhniy Novgorod
Russian Federation	MUZ City Clinical Hospital 2	Novosibirsk
Russian Federation	Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so	Obninsk
Russian Federation	Saratov State Medical University	Saratov
Russian Federation	Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies	St. Petersburg
Russian Federation	FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency	St. Petersburg
Russian Federation	GUS Leningrad Regional Clinical Hospital	St. Petersburg
Russian Federation	St. Petersburg Pavlov State Medical Univ	St.Petersburg
Russian Federation	GUZ Volgograd Regional Clinical Oncology	Volgograd
South Africa	Groote Schuur Hospital	Cape Town
South Africa	University Witwatersrand Oncology	Parktown
South Africa	Mary Potter Oncology Centre	Pretoria
South Africa	Pretoria Academic Hospital	Pretoria
South Africa	Wilgers Oncology CentreWilgrers Hospital	Pretoria
Spain	Hospital Germans Trias I Pujol	Badalona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Vall D hebron	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda
Spain	Virgen de la Victoria Hospital Malaga	Malaga
Spain	Hospital General Universitario Morales Messeguer	Murcia
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Donostia	San Sebastian
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Clinico Universitario	Valencia
Sweden	Skane University Hospital	Lund
Sweden	Karolinska University	Stockholm
Sweden	Stockholm South Hospital	Stockholm
United Kingdom	Royal Bournemouth General Hospital	Bournemouth
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Gartnavel General Hospital	Glasgow
United Kingdom	John Radcliffe Hospital	Headington
United Kingdom	Saint James University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Guy's and St. Thomas' Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	St George's Healthcare NHS Trust	London
United Kingdom	St. Bartholomew's and The Royal London Hospital	London
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust	Sheffield
United Kingdom	Singleton Hospital, Southwest Wales Cancer Inst	Swansea
United Kingdom	Sandwell Hospital	West Bromwich
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	McFarland Clinic	Ames	Iowa
United States	Augusta Oncology Associates, P.C.	Augusta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Boca Raton Community Hospital	Boca Raton	Florida
United States	Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital	Boston	Massachusetts
United States	Pasco Hernando Oncology Associates, PA	Brooksville	Florida
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Charleston Hematology Oncology P.A.	Charleston	South Carolina
United States	Northwestern University, Division of Hematology Oncology, Dept. of Medicine	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Hematology Oncology Consultants, Inc.	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Gabrail Cancer Center Research	Dover	Ohio
United States	Pacific Coast Hematology Oncology	Fountain Valley	California
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	The Cancer Center, Hackensack University Medical Center	Hackensack	New Jersey
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Edward Hines Jr VA Hospital	Hines	Illinois
United States	Memorial Hospital	Hollywood	Florida
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Gundersen Clinic Lutheran Hospital	La Crosse	Wisconsin
United States	Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute	Marietta	Georgia
United States	Winthrop University Hospital	Mineola	New York
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services	New Albany	Indiana
United States	Biomedical Research Alliance of New York, LLC	New Hyde Park	New York
United States	Ochsner Medical Institutions	New Orleans	Louisiana
United States	North Chicago VA Medical Center	North Chicago	Illinois
United States	Drexel University, College of Medicine, Clinical Research Group	Philadelphia	Pennsylvania
United States	Mayo Clinic - Arizona	Phoenix	Arizona
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Cancer Center of Central Connecticut	Plainville	Connecticut
United States	Kaiser Permanente Northwest Oncology Hematology	Portland	Oregon
United States	Kaiser Permanente Medical Group	San Diego	California
United States	Sharp Memorial Hospital	San Diego	California
United States	Swedish Cancer Institute	Seattle	Washington
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	Hematology Oncology Assoc. of IL Orchard Research LLC	Skokie	Illinois
United States	Stanford University Stanford	Stanford	California
United States	M. Francisco Gonzalez, MD, PA	Sumter	South Carolina
United States	SUNY Upstate Medical University Medicine Oncology	Syracuse	New York
United States	Florida Cancer Specialist	Tavares	Florida
United States	Florida Hospital Cancer Institute Waterman	Tavares	Florida
United States	Westchester County Medical Center	Valhalla	New York
United States	Wenatchee Valley Hospital and Clinics	Wenatchee	Washington
United States	Abington Hematology Oncology Associates Inc	Willow Grove	Pennsylvania
United States	Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	Trilogy Cancer Care	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Colombia,  Czechia,  Denmark,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.	Up to approximately 11 years
Secondary	Progression Free Survival 2 (PFS2)	Progression Free Survival (PFS2) assessed by investigator is defined as the time from randomization to the second objective disease progression, or death from any cause, whichever occurs first.	Up to 6 years
Secondary	Number of Participants With Adverse Events (AEs)	Number of participants with adverse events (AEs) that measure type, frequency and severity of AEs graded by National Cancer Institute Common Terminology Criteria (NCI CTCAE V 3.0) including any grade adverse events (AEs), Grade 3-4 AEs, AEs related to study drug, grade 3-4 AEs related to study drug.	From first dose to 30 days post last dose (up to 9 years)