A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.

NCT ID: NCT00405756

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2016-04-30

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.

Conditions

Newly Diagnosed Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MPR+R

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

Group Type: EXPERIMENTAL

Lenalidomide: Double-blind Induction

Intervention Type: DRUG

Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Melphalan

Intervention Type: DRUG

Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Prednisone

Intervention Type: DRUG

Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Aspirin

Intervention Type: DRUG

Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.

Double-blind maintenance: at the investigator's discretion

Lenalidomide: Double-blind Maintenance

Intervention Type: DRUG

Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Lenalidomide: Open-label

Intervention Type: DRUG

Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.

MPR+p

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

Group Type: EXPERIMENTAL

Lenalidomide: Double-blind Induction

Intervention Type: DRUG

Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Melphalan

Intervention Type: DRUG

Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Prednisone

Intervention Type: DRUG

Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Aspirin

Intervention Type: DRUG

Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.

Double-blind maintenance: at the investigator's discretion

Placebo

Intervention Type: DRUG

Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.

Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Lenalidomide: Open-label

Intervention Type: DRUG

Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.

MPp+p

Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

Group Type: OTHER

Melphalan

Intervention Type: DRUG

Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Prednisone

Intervention Type: DRUG

Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Aspirin

Intervention Type: DRUG

Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.

Double-blind maintenance: at the investigator's discretion

Placebo

Intervention Type: DRUG

Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.

Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Lenalidomide: Open-label

Intervention Type: DRUG

Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.

Interventions

Lenalidomide: Double-blind Induction

Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Intervention Type: DRUG

Melphalan

Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Intervention Type: DRUG

Prednisone

Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Intervention Type: DRUG

Aspirin

Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.

Double-blind maintenance: at the investigator's discretion

Intervention Type: DRUG

Placebo

Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.

Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Intervention Type: DRUG

Lenalidomide: Double-blind Maintenance

Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Intervention Type: DRUG

Lenalidomide: Open-label

Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.

Intervention Type: DRUG

Other Intervention Names

Revlimid; Alkeran; Revlimid; Revlimid

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Palumbo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

Locations

Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre

South Brisbane, Queensland, Australia

Royal Adelaide Hospital Institute of Medical and Veterinary Science

Adelaide, South Australia, Australia

Royal Prince Alfred Hospital

Camperdown, , Australia

Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology

East Melbourne, , Australia

Frankston Hospital

Frankston, , Australia

The Alfred Hospital

Melbourne, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

University Hospital Innsbruck

Innsbruck, , Austria

University Hospital of Salzburg St Johanns Spital

Salzburg, , Austria

Medical University of Vienna

Vienna, , Austria

Wilhelminenspital

Vienna, , Austria

Medical University of Vienna

Vienna, , Austria

Republican Scientific and Practical Centre of Radiation Medicine and Human Ecology

Homyel, , Belarus

City Clinical Hospital 9

Minsk, , Belarus

AZ St-Jan Brugge Oostende AV

Bruges, , Belgium

AZ-VUB

Brussels, , Belgium

UZ Gasthuisberg

Leuven, , Belgium

Centre Hospitalier Universitaire de Liege

Liège, , Belgium

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Fakultni Nemocnice Olomouc

Olomouc, , Czechia

Vseobecna Fakultni Nemocnice v Praze

Prague, , Czechia

Hæmatologisk afd. B Aalborg Sygehus Syd

Aalborg, , Denmark

Medicinsk afd. Vejle Sygehus

Vejle, , Denmark

CHU

Caen, , France

CH - Hôpital Dupuytren

Limoges, , France

CHU Montpellier- Hopital Lapeyronie

Montpellier, , France

Assistance Publique - Hôpitaux de Paris AP-HP

Paris, , France

CHU Purpan

Toulouse, , France

Ltd M.Zodelava Hematology Centre

Tbilisi, , Georgia

Institute of Hematology and Transfusiology

Tbilisi, , Georgia

Medizinische Klinik und Poliklinik II der Charite Campus Mitte

Berlin, , Germany

Universitatsklinikum Carl Gustav Carus an der TU Dresden

Dresden, , Germany

Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

Freiburg im Breisgau, , Germany

Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, , Germany

Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

Heidelberg, , Germany

Medizinische Klinik und Poliklinik II

Leipzig, , Germany

Poliklinik A

Münster, , Germany

Medizinische Klinik - Abteilung II

Tübingen, , Germany

Medizinische Universitatsklinik

Ulm, , Germany

Medizinische Klinik und Poliklinik II des Universitatsklinikums Wurzburg

Würzburg, , Germany

G. GENNIMATAS General Hospital of Athens Department of Hematolgosy

Athens, , Greece

General Air Force Hospital

Athens, , Greece

Alexandra General Hospital of Athens

Athens, , Greece

Hope Directorate Haematology Oncology Service St. James Hospital

Dublin, , Ireland

Midlands Regional

Tullamore / Co Offally, , Ireland

Rambam Medical Center

Haifa, , Israel

Hadassah University Hospital

Jerusalem, , Israel

Hematology Institute, Hemato-Oncology Division,Davidoff Cancer Center, Rabin MC Beilinson Hospital

Petch Tikva, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Policlinico S. Orsola

Bologna, , Italy

A.O.U. San Martino

Genova, , Italy

Dipartmento Oncologico Struttura Complessa di ematlologiaA.O. Ospedale Niguarda Ca Granda

Milan, , Italy

Policlinico San Matteo Universita Di Pavia

Pavia, , Italy

Divisione Di Ematologia Ospedale Cattedra di Ematologia

Rome, , Italy

Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

Rome, , Italy

Dipartimento di Onco-Ematologia

San Giovanni Rotondo (FG), , Italy

Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

Turin, , Italy

VU Medical Center

Amsterdam, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Klinika Hematologii Samodzielny Publiczny Szpital Kliniczny Akademii

Bialystok, , Poland

Institute of Internal Diseases University of Medicine

Gdansk, , Poland

Oddzial Kliniczny Kliniki Hematologii

Krakow, , Poland

Uniwersytet Medyczny w Lodzi

Lodz, , Poland

University School of Medicine

Lublin, , Poland

Akademia Medyczna w Warszawie Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, , Poland

Burdenko Central Military Clinical Hospital

Moscow, , Russia

Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

Moscow, , Russia

Moscow Regional Research Institute n.a. Vladimirsky

Moscow, , Russia

Novosibirsk State Regional Clinical Hospital

Novosibirsk, , Russia

Medical Radiological Research Center RAMS

Obninsk, , Russia

St. Petersburg Research Institute of Hematology and Blood Transfusion

Saint Petersburg, , Russia

Samara Regional Clinical Hospital

Samara, , Russia

Hospital Clinic

Barcelona, , Spain

Hospital Universitaro Puerta del MarServicio de Hematologia

Cadiz, , Spain

Hospital Universitario de la Princessa

Madrid, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Virgen del Rocio Servicio de Hematologia

Seville, , Spain

Medicinkliniken

Borås, , Sweden

Medicinska kliniken

Malmo, , Sweden

UniversitatsSpital ZurichKlinik fur Onkologie

Zurich, , Switzerland

Ankara University

Ankara, , Turkey (Türkiye)

Marmara School of Medicine

Istanbul, , Turkey (Türkiye)

Ege University Medical School

Izmir, , Turkey (Türkiye)

Cherkassy Regional Oncology Center

Cherkassy, , Ukraine

Dnepropetrovsk City Clinical Hospital 4

Dnipro, , Ukraine

Institute of Urgent and Recovery Surgery

Donetsk, , Ukraine

Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

Kiev, , Ukraine

Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

Lviv, , Ukraine

Zhitomir Regional Clinical Hospital

Zhytomyr, , Ukraine

Monklands Hospital

Aidrie, , United Kingdom

St James's University Hospital

Leeds, , United Kingdom

University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Christie NHS Trust Hospital

Manchester, , United Kingdom

Countries

Australia; Austria; Belarus; Belgium; Czechia; Denmark; France; Georgia; Germany; Greece; Ireland; Israel; Italy; Netherlands; Poland; Russia; Spain; Sweden; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 23242595 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22571200 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25840600 (View on PubMed)

Other Identifiers

2006-001865-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-5013-MM-015

Identifier Type: -

Identifier Source: org_study_id