Clinical trial NCT00405756: A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
Official title: A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In Subjects With Newly Diagnosed Multiple Myeloma Who Are 65 Years Of Age Or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Newly Diagnosed Multiple Myeloma
Keywords: Newly Diagnosed Multiple Myeloma
Celgene
CC-5013
Revlimid
Lenalidomide
Melphalan
Prednisone
Elderly
Lead sponsor: Celgene Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 459
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.

Detailed description: The three phases for the study as originally defined and as represented in the results of 11 May 2010 are:

Double-blind Treatment Phase: Induction Melphalan/prednisone and lenalidomide 10 mg (MPR) (2 treatment arms), or melphalan/prednisone and placebo (MPp) (1 treatment arm) for up to 9 cycles. If disease progression, subjects have the option to enter into the Open-Label Extension Phase. There is also an option to enter into the Follow-Up Phase. If the disease has not progressed, subject can continue on blinded therapy into Maintenance.

Double-blind Treatment Phase: Maintenance One MPR treatment arm (MPR+R) will continue taking lenalidomide 10 mg in Maintenance. The other MPR treatment arm (MPR+p) will take placebo in Maintenance. The MP p treatment arm will take placebo in Maintenance (MPp+p). If disease progression, subjects have the option to enter the Open-Label Extension Phase to obtain treatment with lenalidomide, or to enter into the Follow-up Phase.

Open-label Extension Phase:

Treatment consists of oral lenalidomide (up to 25 mg) with or without dexamethasone until disease progression or treatment is discontinued for any reason until all study subjects are followed for at least 5 years from the date of randomization or have died. Subjects who discontinue from the Open-Label Extension Phase prior to completing a total of 5 years in the study will enter the Follow-up Phase.

Follow-up Phase:

Subjects are followed for overall survival and subsequent anti-myeloma treatment regimens until all subjects in this study are followed for at least 5 years from randomization or have died.

The pre-planned interim analysis for the Independent Data Monitoring Committee (IDMC) showed that the difference in progression-free survival (PFS) between treatment arms MPR+R and MPp+p (the defined primary comparative analysis for this study) surpassed the pre-specified O'Brien-Fleming boundary for superiority. The IDMC recommended the release of this information to the sponsor and also recommended that all patient and physician study participants receive information concerning the full findings of the MM-015 interim analysis. Therefore, due to these recommendations from the IDMC, treatment-arm codes were sent to the clinical trial centers to unblind the treatment arms of their study subjects once the amended protocol was reviewed and approved by the respective country Health Authorities and Ethics Committees. Subject participation in the MM-015 study continued after unblinding to obtain long-term data for all study endpoints, including overall survival.

When the study was unblinded, subjects still on protocol therapy had completed the Double-Blind Induction, and were on monotherapy in Double-Blind Maintenance. Subjects in arm MPR+R continued their monotherapy on lenalidomide. Subjects in arms MPR+p and MPp+p discontinued their placebo monotherapy and went into an observation period in which no antimyeloma therapy was taken. If disease progressed for any subject, the investigator had the option of entering the subject in Open Label Extension Phase to receive lenalidomide therapy (up to 25 mg daily) or the Follow-up Phase. All subjects were to be followed for at least 5 years from the start of the study.

Eligibility criteria: Inclusion Criteria

1. Must understand and voluntarily sign an informed consent form
2. Age greater than or equal to 65 years at the time of signing the informed consent
3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below:

MM diagnostic criteria (all of next 3 required)

1. Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
2. Monoclonal protein present in the serum and/or urine
3. Myeloma-related organ dysfunction (at least one of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5mg/dl or upper limit of normal) \[R\] Renal insufficiency (serum creatinine \>2mg/dl) \[A\] Anemia (hemoglobin \<10g/dl or 2g \< normal) \[B\] Lytic bone lesions or osteoporosis AND have measurable disease as defined by the following; IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgA multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgD multiple myeloma: Serum M-protein level greater than or equal to 0.05 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level greater than or equal to 1.0g/dL or urine M-protein level greater than or equal to 200mg/24hours
4. Karnofsky performance status greater than or equal to 60%.
5. Able to adhere to the study visit schedule and other protocol requirements.
6. Women of Childbearing potential (WCBP) must:

   a. Have a negative medically supervised pregnancy test prior to the start 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 and continues sexual abstinence.

   b Either commit to 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 dose interruptions), and for 28 days after discontinuation of study therapy.
7. Males Subjects must:

   1. Agree to use a condom during sexual contact with a WCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after the cessation of study therapy.
   2. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
8. All subjects must

   1. Have an understanding that the study drug could have 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.
   4. All patients must be counseled about pregnancy precautions and risks of fetal exposure.

Female Subjects:

Females of childbearing potential (FCBP) with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study.

In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit. Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood.

Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation.

Females must agree to abstain from breastfeeding during study participation and for at least 28 days after the discontinuation from the study.

Male Subjects:

Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen.

If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a study subject during study participation, study drug must be immediately discontinued.

Exclusion Criteria

1. Previous treatment with antimyeloma 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 28 days \[4 weeks\] of randomization\]).
2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study.
3. Pregnant or lactating females.
4. Radiotherapy within 14 days (2 weeks) of randomization.
5. Plasmapheresis within 28 days (4 weeks) of randomization.
6. Any of the following laboratory abnormalities:

   Absolute neutrophil count (ANC) \< 1,500 cells/mL (1.5\*10\^9/L) Platelet count \< 75,000 cells/uL (75\*10\^9/L) for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; but platelet count \<30,000/uL for subjects in whom \>= 50% of bone marrow nucleated cells are plasma cells Haemoglobin \< 8.0 g/dL (80 g/L) Serum creatinine \> 2.5 mg/dL (221 µmol/L) Serum aspartate aminotransferase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) \> 3.0 times upper limit of normal (ULN)
7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for greater than or equal to 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 histologic finding of prostate cancer (TNM Classification of Malignant Tumours (TNM) stage of T1a or T1b)
8. Neuropathy of \>= grade 2 severity.
9. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis, type A, B or C.

Primary outcomes:
measure: Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)
timeFrame: up to 165 weeks
Secondary outcomes:
measure: Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)
timeFrame: Approximately week 37 (start of cycle 10) to week 165
measure: Kaplan Meier Estimates of Overall Survival (OS)
timeFrame: up to 177 weeks
measure: Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)
timeFrame: up to 165 weeks
measure: Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period
timeFrame: Up to 165 weeks
measure: Time to First Response
timeFrame: Up to 66 weeks
measure: Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)
timeFrame: Up to 149 weeks
measure: Kaplan Meier Estimates for Time to Next Antimyeloma Therapy
timeFrame: Up to 168 weeks
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period
timeFrame: Up to 169 weeks (Double-blind therapy period plus 4 weeks)
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
measure: Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale
timeFrame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Other outcomes:
Locations:
city: South Brisbane
country: Australia
facility: Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science
state: South Australia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
city: Frankston
country: Australia
facility: Frankston Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
city: Salzburg
country: Austria
facility: University Hospital of Salzburg St Johanns Spital
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Gomel
country: Belarus
facility: Republican Scientific and Practical Centre of Radiation Medicine and Human Ecology
city: Minsk
country: Belarus
facility: City Clinical Hospital 9
city: Brugge
country: Belgium
facility: AZ St-Jan Brugge Oostende AV
city: Brussels
country: Belgium
facility: AZ-VUB
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czech Republic
facility: Fakultni Nemocnice Olomouc
city: Prague
country: Czech Republic
facility: Vseobecna Fakultni Nemocnice v Praze
city: Aalborg
country: Denmark
facility: Hæmatologisk afd. B Aalborg Sygehus Syd
city: Vejle
country: Denmark
facility: Medicinsk afd. Vejle Sygehus
city: Caen
country: France
facility: CHU
city: Limoges Cedex 1
country: France
facility: CH - Hôpital Dupuytren
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier- Hopital Lapeyronie
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris AP-HP
city: Toulouse cedex 9
country: France
facility: CHU Purpan
city: Tbilisi
country: Georgia
facility: Ltd M.Zodelava Hematology Centre
city: Tbilisi
country: Georgia
facility: Institute of Hematology and Transfusiology
city: Berlin
country: Germany
facility: Medizinische Klinik und Poliklinik II der Charite Campus Mitte
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
city: Leipzig
country: Germany
facility: Medizinische Klinik und Poliklinik II
city: Münster
country: Germany
facility: Poliklinik A
city: Tübingen
country: Germany
facility: Medizinische Klinik - Abteilung II
city: Ulm
country: Germany
facility: Medizinische Universitatsklinik
city: Würzburg
country: Germany
facility: Medizinische Klinik und Poliklinik II des Universitatsklinikums Wurzburg
city: Athens
country: Greece
facility: G. GENNIMATAS General Hospital of Athens Department of Hematolgosy
city: Athens
country: Greece
facility: General Air Force Hospital
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Dublin
country: Ireland
facility: Hope Directorate Haematology Oncology Service St. James Hospital
city: Tullamore / Co Offally
country: Ireland
facility: Midlands Regional
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Petch Tikva
country: Israel
facility: Hematology Institute, Hemato-Oncology Division,Davidoff Cancer Center, Rabin MC Beilinson Hospital
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Bologna
country: Italy
facility: Policlinico S. Orsola
city: Genova
country: Italy
facility: A.O.U. San Martino
city: Milano
country: Italy
facility: Dipartmento Oncologico Struttura Complessa di ematlologiaA.O. Ospedale Niguarda Ca Granda
city: Pavia 2
country: Italy
facility: Policlinico San Matteo Universita Di Pavia
city: Rome
country: Italy
facility: Divisione Di Ematologia Ospedale Cattedra di Ematologia
city: Rome
country: Italy
facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
city: San Giovanni Rotondo (FG)
country: Italy
facility: Dipartimento di Onco-Ematologia
city: Turin
country: Italy
facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bialystok
country: Poland
facility: Klinika Hematologii Samodzielny Publiczny Szpital Kliniczny Akademii
city: Gdansk
country: Poland
facility: Institute of Internal Diseases University of Medicine
city: Krakow
country: Poland
facility: Oddzial Kliniczny Kliniki Hematologii
city: Lodz
country: Poland
facility: Uniwersytet Medyczny w Lodzi
city: Lublin
country: Poland
facility: University School of Medicine
city: Warsaw
country: Poland
facility: Akademia Medyczna w Warszawie Samodzielny Publiczny Centralny Szpital Kliniczny
city: Moscow
country: Russian Federation
facility: Burdenko Central Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Institute n.a. Vladimirsky
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Center RAMS
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Research Institute of Hematology and Blood Transfusion
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Cadiz
country: Spain
facility: Hospital Universitaro Puerta del MarServicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princessa
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio Servicio de Hematologia
city: Boras
country: Sweden
facility: Medicinkliniken
city: Malmö
country: Sweden
facility: Medicinska kliniken
city: Zurich
country: Switzerland
facility: UniversitatsSpital ZurichKlinik fur Onkologie
city: Ankara
country: Turkey
facility: Ankara University
city: Istanbul
country: Turkey
facility: Marmara School of Medicine
city: Izmir
country: Turkey
facility: Ege University Medical School
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Oncology Center
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk City Clinical Hospital 4
city: Donetsk
country: Ukraine
facility: Institute of Urgent and Recovery Surgery
city: Kiev
country: Ukraine
facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
city: Lviv 79044
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine
city: Zhitomir
country: Ukraine
facility: Zhitomir Regional Clinical Hospital
city: Aidrie
country: United Kingdom
facility: Monklands Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Christie NHS Trust Hospital
Study officials:
affiliation: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
name: Antonio Palumbo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dimopoulos MA, Delforge M, Hajek R, Kropff M, Petrucci MT, Lewis P, Nixon A, Zhang J, Mei J, Palumbo A. Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial. Haematologica. 2013 May;98(5):784-8. doi: 10.3324/haematol.2012.074534. Epub 2012 Dec 14.
citation: Palumbo A, Hajek R, Delforge M, Kropff M, Petrucci MT, Catalano J, Gisslinger H, Wiktor-Jedrzejczak W, Zodelava M, Weisel K, Cascavilla N, Iosava G, Cavo M, Kloczko J, Blade J, Beksac M, Spicka I, Plesner T, Radke J, Langer C, Ben Yehuda D, Corso A, Herbein L, Yu Z, Mei J, Jacques C, Dimopoulos MA; MM-015 Investigators. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. N Engl J Med. 2012 May 10;366(19):1759-69. doi: 10.1056/NEJMoa1112704.
citation: Dimopoulos MA, Petrucci MT, Foa R, Catalano J, Kropff M, Terpos E, Zhang J, Grote L, Jacques C, Palumbo A; MM-015 Investigators. Impact of maintenance therapy on subsequent treatment in patients with newly diagnosed multiple myeloma: use of "progression-free survival 2" as a clinical trial end-point. Haematologica. 2015 Aug;100(8):e328-30. doi: 10.3324/haematol.2014.120790. Epub 2015 Apr 3. No abstract available.