Clinical trial NCT00689936: Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
Official title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: newly diagnosed multiple myeloma
Lenalidomide
Revlimid
phase III
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 1623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

Detailed description: CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease \[PD\] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.

Eligibility criteria: Inclusion Criteria:

1. Must understand and voluntarily sign informed consent form
2. Age ≥ 18 years at the time of signing consent
3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:

   * MM diagnostic criteria (all 3 required):
   * Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
   * Monoclonal protein present in the serum and/or urine
   * Myeloma-related organ dysfunction (at least one of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5 mg/dl or upper limit of normal) \[R\] Renal insufficiency (serum creatinine \>2 mg/dl) \[A\] Anemia (hemoglobin \<10 g/dl or 2 g \< laboratory normal) \[B\] Lytic bone lesions or osteoporosis

   AND have measurable disease by protein electrophoresis analyses as defined by the following:
   * IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
   * IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
   * IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
   * IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
   * Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours

   AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:
   * The patient declines to undergo stem cell transplantation or
   * Stem cell transplantation is not available to the patient due to cost or other reasons
4. ECOG performance status of 0, 1, or 2
5. Able to adhere to the study visit schedule and other protocol requirements
6. Females of child-bearing potential (FCBP)\^2:

   1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
   2. Must commit to either continued abstinence from heterosexual intercourse (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 during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
7. Male Patients:

   1. Must 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.
   2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
   3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
8. All patients must:

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

Exclusion Criteria:

1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
3. Pregnant or lactating females.
4. Any of the following laboratory abnormalities:

   * Absolute neutrophil count (ANC) \< 1,000/µL (1.0 x 109/L)
   * Untransfused platelet count \< 50,000 cells/µL (50 x 10\^9/L)
   * Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)
5. Renal failure requiring hemodialysis or peritoneal dialysis.
6. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 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 histological finding of prostate cancer (TNM stage of T1a or T1b)
7. Patients who are unable or unwilling to undergo antithrombotic therapy.
8. Peripheral neuropathy of \> grade 2 severity.
9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.

   * 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
   * 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Primary outcomes:
measure: Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
timeFrame: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
measure: Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
timeFrame: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Secondary outcomes:
measure: Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
timeFrame: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
measure: Percentage of Participants With an Objective Response Based on IRAC Review
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
measure: Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
timeFrame: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
measure: Time to First Response Based on the Review by the IRAC
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
measure: Kaplan Meier Estimates of Time to Treatment Failure (TTF)
timeFrame: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
measure: Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
timeFrame: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
measure: Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
timeFrame: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
measure: Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
timeFrame: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
measure: Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
timeFrame: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
timeFrame: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
measure: Change From Baseline in the EORTC QLQ-C30 Pain Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Constipation Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
timeFrame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
measure: Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
timeFrame: Day 1 (randomization) up to last visit completed 25 July 2016
measure: Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
timeFrame: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
timeFrame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
timeFrame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
timeFrame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
timeFrame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
measure: Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base
timeFrame: From randomization to 24 May 2013
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of AL Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedar Sinai Medical Center Dept of Medicine
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco- California
state: California
city: Stanford
country: United States
facility: Stanford University Stanford
state: California
city: Gainesville
country: United States
facility: Gainesville Heme Oncology Associates
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Orange Park
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Saint Petersburg
country: United States
facility: Gulf Coast Oncology
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute, LLC
state: Florida
city: Centralia
country: United States
facility: Southern Illinois Hematology Oncology
state: Illinois
city: Chicago
country: United States
facility: Orchard Healthcare Research, Inc.
state: Illinois
city: Chicago
country: United States
facility: John H Stroger Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Institute
state: Illinois
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine Blood Disorders
state: Maine
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Lake Success
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: Fargo
country: United States
facility: Dakota Cancer Institute
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Northwest Oncology Hematology
state: Oregon
city: Allentown
country: United States
facility: St. Luke's Hospital and Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Collierville
country: United States
facility: The Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: E. Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Geelong
country: Australia
facility: Geelong Hospital
city: Gosford
country: Australia
facility: Gosford Hospital
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Malvern
country: Australia
facility: Cabrini Hospital
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Southport
country: Australia
facility: Gold Coast Hospital
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Wentworthville
country: Australia
facility: Westmead Hospital
city: Wodonga
country: Australia
facility: Border Medical Oncology
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Leoben
country: Austria
facility: Hospital Leoben
city: Linz
country: Austria
facility: Hospital of Barmherzige Schwestern Linz
city: Linz
country: Austria
facility: Hospital of Elisabethinen Linz
city: Linz
country: Austria
facility: General Hospital Linz
city: Salzburg
country: Austria
facility: MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
city: St. Pölten
country: Austria
facility: Hospital St. Polten
city: Vienna
country: Austria
facility: Hospital of the Barmherzigen Bruder Vienna
city: Vienna
country: Austria
facility: MM-015.Wihelminenspital
city: Vienna
country: Austria
facility: MM-015. Medizinische Universität Wien
city: Wels
country: Austria
facility: Hospital Wels
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg Centrumziekenhuis
city: Arlon
country: Belgium
facility: Les Cliniques du Sud Luxembourg
city: Brugge
country: Belgium
facility: AZ St-Jan Brugge Oostende AV
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Brussels
country: Belgium
facility: AZ-VUB
city: Brussel
country: Belgium
facility: Jules Bordet Institut
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg
city: Roeselare
country: Belgium
facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godine
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Surrey
country: Canada
facility: BC Cancer Agency - Fraser Valley Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Cancer Center
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Hospital Charles LeMoyne
state: Quebec
city: Laval
country: Canada
facility: Hopital de la Cite-de-la-Sante
state: Quebec
city: Levis
country: Canada
facility: Hotel-Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Hospital Maisonneuve - Rosemont
state: Quebec
city: Montreal
country: Canada
facility: CHUM- Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish Genl
state: Quebec
city: Quebec
country: Canada
facility: CHUQ - Hotel-Dieu de QuebecHematology - Oncology
city: Beijing
country: China
facility: Chaoyang Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University
city: Tianjin
country: China
facility: Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
city: Albi
country: France
facility: Clinique Claude BernardOncologie
city: Amiens
country: France
facility: CHU Sud
city: Angers cedex 01
country: France
facility: CHRU Hopital du bocage
city: Argenteuil
country: France
facility: CH Argenteuil Victor Dupouy
city: Bayonne
country: France
facility: Centre Hospitalier de la cote basque
city: Blois cedex
country: France
facility: Centre Hospitalier
city: Bobigny Cedex
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Bourg en Bresse cedex
country: France
facility: Hopital de Fleyriat
city: Brest cedex
country: France
facility: Hopital Augustin Morvan
city: Caen cedex 5
country: France
facility: Centre Francois Baclesse
city: Caen
country: France
facility: CHU
city: Cannes Cedex
country: France
facility: CH
city: Cergy-Pontoise
country: France
facility: CH Rene Dubois
city: Chalon/Saone Cedex
country: France
facility: Centre Hospitalier William Morey
city: Clamart Cedex
country: France
facility: Hopital dinstruction des armees Percy
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Clermont Ferrand
country: France
facility: Chu Estaing
city: Colmar cedex
country: France
facility: CH Louis Pasteur
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHRU Hopital du bocage
city: Dunkerque
country: France
facility: Centre Hospitalier General
city: Grenoble cedex 09
country: France
facility: CHRU
city: Grenoble
country: France
facility: Institut Prive de Cancerologie
city: La Roche -Sur-Yon cedex 9
country: France
facility: Centre Hospitalier Departemental
city: Le Chesnay Cedex
country: France
facility: CH
city: Le Havre
country: France
facility: Hopital J MonodRhumato Nord
city: Le Kremlin bicetre CDX
country: France
facility: Kremlin Bicetre
city: Le Mans cedex
country: France
facility: Centre Hospitalier
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Lille cedex
country: France
facility: CHRU-Hopital Claude Huriez
city: Lille
country: France
facility: GH de Institut Catholique St Vincent
city: Limoges Cedex 1
country: France
facility: CH - Hôpital Dupuytren
city: Lyon cedex
country: France
facility: CHU Hopital Edouard Herriot
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Centre Hospitalier de Valence
city: Marseille Cedex 9
country: France
facility: Institut Paoli-Calmettes
city: METZ cedex 3
country: France
facility: Hopital de Mercy
city: Montauban cedex
country: France
facility: Clinique Pont de chaume Oncologie et Radiotherapie
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Lapeyronie
city: Mulhouse
country: France
facility: Hopital Emile Muller
city: Nantes
country: France
facility: CHRU - Hotel Dieu
city: Nice cedex 1
country: France
facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie
city: Nice cedex 3
country: France
facility: Hopital de lArchet 1
city: Orleans
country: France
facility: CH La Source
city: Paris Cedex 14
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: CHU Hôpital St-Antoine
city: Pessac
country: France
facility: CHRU - Hopital du Haut Leveque
city: Poitiers cedex
country: France
facility: CU CHU Clemenceau
city: Reims cedex
country: France
facility: Hopital R. Debre
city: Reims
country: France
facility: CHU Reims - Hôpital Maison Blanche
city: Rennes cedex 02
country: France
facility: CHRU Hopital sud Medecine Interne
city: Rennes Cedex
country: France
facility: CHRU Hôpital de Pontchaillou
city: Rodez
country: France
facility: CHG Rodez
city: Rouen cedex
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: St Priest en Jarez
country: France
facility: Institut de Cancerologie de Loire
city: St-Brieuc cedex 1
country: France
facility: Centre Hospitalier Yves Le Foll
city: Strasbourg
country: France
facility: CHRU Hôpital de Hautepierre
city: Toulouse cedex 9
country: France
facility: CHRU Hopital Purpan
city: Tours cedex
country: France
facility: CHRU Hopital Bretonneau
city: Tours
country: France
facility: CHRU Hopital Trousseau
city: Vandoeuvre Cedex
country: France
facility: CHRU Hôpitaux de Brabois
city: Vannes cedex
country: France
facility: CH P. Chubert
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Dresden
country: Germany
facility: Medizinische Kinik und Poliklinik I
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
city: Essen
country: Germany
facility: Universitatsklinikum Essen-
city: Frankfurt am Main
country: Germany
facility: Staedtische Kliniken Frankfurt am Main Hochst
city: Giessen
country: Germany
facility: Universitatsklinikum Giessen
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Hamburg
country: Germany
facility: Askepios Klinik St. Georg
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Leipzig
country: Germany
facility: Medizinische Klinik und Poliklinik II
city: Lübeck
country: Germany
facility: Universitatsklinikum schleswig-Holstein
city: Muenster
country: Germany
facility: Poliklinik A
city: München
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe-Universtat
city: München
country: Germany
facility: Medizinische Klinik III Klinikum der Universität München-Großhadern
city: Rostock
country: Germany
facility: Medizinische Fakultat der Universitat Rostock
city: Stuttgart
country: Germany
facility: Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
city: Tübingen
country: Germany
facility: Medizinische Klinik - Abteilung II
city: Ulm
country: Germany
facility: Klinik fur Innere Medizin III
city: Athens
country: Greece
facility: Alexandra Hospital, University of Athens
city: Athens
country: Greece
facility: Attiko Hospital of Athens
city: Athens
country: Greece
facility: Evangelismos Hospital of Athens
city: Athens
country: Greece
facility: University of Athens
city: Piraeus
country: Greece
facility: Metaxa Hospital Peiraias
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital of Thessaloniki
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital
city: Dublin
country: Ireland
facility: Mater Misercordiae Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Bologna
country: Italy
facility: Policlinico S. Orsola
city: Catanzaro
country: Italy
facility: Oncologia Medica, Università della Magna Grecia
city: Genova
country: Italy
facility: Clinica Ematologica, A.O.U. San Martino di Genova
city: Lecce
country: Italy
facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
city: Matera
country: Italy
facility: Unità Operativa di Oncoematologia, Ospedale di Matera
city: Milano
country: Italy
facility: U.O. di Ematologia e Trapianto di Midollo Osseo
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia - IEO
city: Milano
country: Italy
facility: Presidio Ospedaliero A. Perrino
city: Modena
country: Italy
facility: Policlinico di Modena
city: Napoli
country: Italy
facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena, Divisione di Ematologia
city: Pavia 2
country: Italy
facility: Policlinico San Matteo Universita Di Pavia
city: Piacenza
country: Italy
facility: Ospedale Civile
city: Pisa
country: Italy
facility: A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
city: Rome
country: Italy
facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
city: Torino
country: Italy
facility: Ospedale Molinette
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center 3056-6
city: Daejon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun-goon
country: Korea, Republic of
facility: Hwasun Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital 42
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seongsanno
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul - Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Newtown
country: New Zealand
facility: Wellington Hospital
city: Braga
country: Portugal
facility: Hospital de Sao Marcos
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Português de Oncologia Porto
city: Porto
country: Portugal
facility: Hospital de Santo Antonio- Porto
city: Badalona (Barcelona)
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia-Hospital Duran
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Girona
country: Spain
facility: Hospital Univ. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Messeguer
city: Málaga
country: Spain
facility: Hospital Clinico Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra,
city: Reus
country: Spain
facility: Hospital Sant Pau
city: San Sebastian
country: Spain
facility: Hospital de Donosti
city: Santander
country: Spain
facility: Hospital Universtario Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Santiago de Compostela
city: Valencia
country: Spain
facility: Hosptial La Fe
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University HospitalSolna
city: Stockholm
country: Sweden
facility: St. Görans Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Aarau
country: Switzerland
facility: Abteilung Onkologie Haematologie des Kantonsspitals Aarau
city: Basel
country: Switzerland
facility: UniversitatsSpital Basel
city: Berne
country: Switzerland
facility: Inselsspital Bern
city: Chur
country: Switzerland
facility: Kantonsspital Graubunden
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois CHUV
city: Münsterlingen (TG)
country: Switzerland
facility: Kantonsspital Munsterlingen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Veteran General Hospital - Taipei
city: Tapei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangor
country: United Kingdom
facility: Gwynedd Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Belfast Northern Ireland
country: United Kingdom
facility: Belfast City Hospital Haematology Department
city: Birmingham West Midlands
country: United Kingdom
facility: Birminghman QE
city: Bournemouth Dorset
country: United Kingdom
facility: Royal Bournemouth Hosp
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales - Cardiff
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Centre
city: London
country: United Kingdom
facility: Dept of Haematology St Bartholomews Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital - London
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Oxford
country: United Kingdom
facility: Churchhill Hospital
city: Plymouth Crownhill Devon
country: United Kingdom
facility: Derriford Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
city: West Yorkshire
country: United Kingdom
facility: Pinderfields General Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital- Wolverhampton
Study officials:
affiliation: Celgene Corporation
name: Christian Jacques, MD
role: STUDY_DIRECTOR
References:
citation: Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.
citation: Hulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.
citation: Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.
citation: Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
citation: Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.
citation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.
citation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.
citation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.
citation: Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.
citation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.
citation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.
citation: Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.
citation: Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.