Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM
NCT ID: NCT02112175
Last Updated: 2021-04-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
46 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-04-30
Study Completion Date
2020-10-12
Brief Summary
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The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma.
After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.
After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.
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A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
NCT00405756
Newly Diagnosed Multiple Myeloma
COMPLETED
PHASE3
Detailed Description
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The planned total number of evaluable subjects for PFS was approximately 351 (234 in the lenalidomide treatment arm; 117 in the placebo treatment arm) and the study will be conducted in European countries. However, due to the significant enrollment challenges and the changes in the NDMM treatment practices in subjects who are not eligible for transplant, such as the recent approval of Revlimid in NDMM setting, the DMC recommended to close study enrollment. Study enrollment was closed on 12 October 2015.
Conditions
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Multiple Myeloma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Lenalidomide
Treatment Arm A: lenalidomide 10 mg/day orally from Days 1 to 21; given in 28-day cycles for up to disease progression.
Group Type
EXPERIMENTAL
Lenalidomide
Intervention Type
DRUG
Interventions
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Lenalidomide
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
Related to initial diagnosis and prior Melphalan Prednisone Velcade (MPV) induction therapy
1. Previously untreated and symptomatic multiple myeloma.
2. All 3 criteria (Durie, 2003) and at least one of the Creatinine Renal insufficiency Anemia lytic Bone lesions or osteoporosis criteria must be met.
3. Measurable disease by protein electrophoresis analyses.
4. All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least Partial Response as best overall response and maintained at Melphalan Prednisone Velcade discontinuation. If a subject achieves Complete Response prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise.
5. Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6-9 cycles of induction therapy with Melphalan Prednisone Velcade.
6. Subjects must have cytogenetic (17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (International Staging System) results from their initial diagnosis available at the time of screening.
Related to the subject
7. Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures,
8. Age ≥ 65 years: if \< 65 years of age, the subject must be non eligible for stem cell transplantation,
9. Eastern Cooperative Oncology Group performance status score ≤ 2,
10. Able to adhere to the study visit schedules and other protocol requirements,
11. Females of Childbearing Potential must:
1. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence2 from heterosexual contact.
2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting Investigational Product, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
12. Male Subjects must:
1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female or childbearing potential while participating in the study, during dose interruptions and for at least 28 days following Investigational Product discontinuation, even if he has undergone a successful vasectomy.
2. Agree to not donate semen during Investigational Product therapy and for 28 days after end of study therapy.
13. All subjects must:
1. Have an understanding that the study medication could have a potential teratogenic risk.
2. Agree to abstain from donating blood while taking Investigational Product therapy and following discontinuation of Investigational Product therapy.
3. Agree not to share study medication with another person.
4. All female of childbearing potential and male subjects must be counseled about pregnancy precautions and risks of fetal exposure.
1. Previously untreated and symptomatic multiple myeloma.
2. All 3 criteria (Durie, 2003) and at least one of the Creatinine Renal insufficiency Anemia lytic Bone lesions or osteoporosis criteria must be met.
3. Measurable disease by protein electrophoresis analyses.
4. All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least Partial Response as best overall response and maintained at Melphalan Prednisone Velcade discontinuation. If a subject achieves Complete Response prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise.
5. Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6-9 cycles of induction therapy with Melphalan Prednisone Velcade.
6. Subjects must have cytogenetic (17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (International Staging System) results from their initial diagnosis available at the time of screening.
Related to the subject
7. Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures,
8. Age ≥ 65 years: if \< 65 years of age, the subject must be non eligible for stem cell transplantation,
9. Eastern Cooperative Oncology Group performance status score ≤ 2,
10. Able to adhere to the study visit schedules and other protocol requirements,
11. Females of Childbearing Potential must:
1. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence2 from heterosexual contact.
2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting Investigational Product, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
12. Male Subjects must:
1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female or childbearing potential while participating in the study, during dose interruptions and for at least 28 days following Investigational Product discontinuation, even if he has undergone a successful vasectomy.
2. Agree to not donate semen during Investigational Product therapy and for 28 days after end of study therapy.
13. All subjects must:
1. Have an understanding that the study medication could have a potential teratogenic risk.
2. Agree to abstain from donating blood while taking Investigational Product therapy and following discontinuation of Investigational Product therapy.
3. Agree not to share study medication with another person.
4. All female of childbearing potential and male subjects must be counseled about pregnancy precautions and risks of fetal exposure.
Exclusion Criteria
* The presence of any of the following will exclude the subject from the study enrollment:
1. Previous treatment with anti-myeloma therapy other than the required 6-9 cycles of Melphalan Prednisone Velcade induction therapy (does not include local radiotherapy, bisphosphonates, or a single short course of steroid \[ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
2. Subjects who didn't achieve Partial Response or better after getting at least 6 cycles of Melphalan Prednisone Velcade and at the end of Melphalan Prednisone Velcade whatever the overall response are not eligible.
3. Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or desoxyribonucleic acid modulating agents. Subjects who received investigational agents are also excluded.
4. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
5. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
6. Pregnant or lactating females.
7. Any of the following laboratory abnormalities:
Absolute neutrophil count \< 1,000/L (1.0 x 10\*9/L) Untransfused platelet count \< 50,000 cells/L (50 x 10\*9/L) Serum glutamic oxaloacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase \> 3.0 x upper limit of normal Serum bilirubin levels \> 1.5 x upper limit of normal
8. Renal insufficiency (creatinine clearance \< 30 mL/min by Cockcroft-Gault method) or actual creatinine clearance result, or renal failure requiring hemodialysis or peritoneal dialysis.
9. Prior history of malignancies including skin cancer, other than multiple myeloma.
10. Prior history of deep venous thrombosis or pulmonary embolus within 3 years of randomization.
11. Subjects who are unable or unwilling to undergo anti-thrombotic therapy.
12. Peripheral neuropathy of \> Grade 2 severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.
13. Known Human Immunodeficiency Virus positivity or active infectious hepatitis, type A, B, or C.
14. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis.
15. Prior allogeneic or autologous stem cell transplantation.
16. Significant active cardiac disease within the previous 6 months including:
New York Heart Association class II-IV congestive heart failure Unstable angina or angina requiring surgical or medical intervention Myocardial infarction
17. Any condition that confounds the ability to interpret data from the study.
1. Previous treatment with anti-myeloma therapy other than the required 6-9 cycles of Melphalan Prednisone Velcade induction therapy (does not include local radiotherapy, bisphosphonates, or a single short course of steroid \[ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
2. Subjects who didn't achieve Partial Response or better after getting at least 6 cycles of Melphalan Prednisone Velcade and at the end of Melphalan Prednisone Velcade whatever the overall response are not eligible.
3. Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or desoxyribonucleic acid modulating agents. Subjects who received investigational agents are also excluded.
4. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
5. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
6. Pregnant or lactating females.
7. Any of the following laboratory abnormalities:
Absolute neutrophil count \< 1,000/L (1.0 x 10\*9/L) Untransfused platelet count \< 50,000 cells/L (50 x 10\*9/L) Serum glutamic oxaloacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase \> 3.0 x upper limit of normal Serum bilirubin levels \> 1.5 x upper limit of normal
8. Renal insufficiency (creatinine clearance \< 30 mL/min by Cockcroft-Gault method) or actual creatinine clearance result, or renal failure requiring hemodialysis or peritoneal dialysis.
9. Prior history of malignancies including skin cancer, other than multiple myeloma.
10. Prior history of deep venous thrombosis or pulmonary embolus within 3 years of randomization.
11. Subjects who are unable or unwilling to undergo anti-thrombotic therapy.
12. Peripheral neuropathy of \> Grade 2 severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.
13. Known Human Immunodeficiency Virus positivity or active infectious hepatitis, type A, B, or C.
14. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis.
15. Prior allogeneic or autologous stem cell transplantation.
16. Significant active cardiac disease within the previous 6 months including:
New York Heart Association class II-IV congestive heart failure Unstable angina or angina requiring surgical or medical intervention Myocardial infarction
17. Any condition that confounds the ability to interpret data from the study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Celgene
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Amine Bensmaine, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour
Baudour, , Belgium
Site Status
AZ-VUB
Brussels, , Belgium
Site Status
Grand Hopital de Charleroi
Charleroi, , Belgium
Site Status
Universitair Ziehenhuis Antwerpen
Edegem, , Belgium
Site Status
Centre Hospitalier de Jolimont-Lobbes
La Louvière-(Haine St-Paul), , Belgium
Site Status
AZ Nikolaas
Sint-Niklaas, , Belgium
Site Status
Cliniques Universitaires UCL de Mont-Godine
Yvoir, , Belgium
Site Status
CH Argenteuil Victor DupouyHematologie
Argenteuil, , France
Site Status
Centre Hospitalier de la cote basque
Bayonne, , France
Site Status
Hopital Jean Minjoz Hematologie
Besançon, , France
Site Status
Centre Hospitalier de Blois
Blois, , France
Site Status
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Site Status
Hopital de Fleyriat
Bourg-en-Bresse, , France
Site Status
Hopital A. MorvanHematologie
Brest, , France
Site Status
CHU de la cote de Nacre
Caen, , France
Site Status
CHRU - Hotel Dieu
Clemont-Ferrand Cedex, , France
Site Status
Chu Estaing
Clermont-Ferrand, , France
Site Status
Centre Hospitalier Sud Francilien - Site Gilles de Corbeil
Corbeil-Essonnes, , France
Site Status
Hopital Henri Mondor
Créteil, , France
Site Status
Centre Hospitalier
Dunkirk, , France
Site Status
CHD Vendee
La Roche-sur-Yon, , France
Site Status
CH Hematologie
Le Chesnay, , France
Site Status
Kremlin Bicetre
Le Kremlin-Bicêtre, , France
Site Status
Centre Jean BernardOnco-Hematologie
Le Mans, , France
Site Status
Centre Hospitalier Medecine interne
Le Mans, , France
Site Status
CHRU Hopital Claude Huriez
Lile Cedax, , France
Site Status
CH - Hôpital Dupuytren
Limoges, , France
Site Status
Centre Hospitalier Regional Metz-Thionville Hopital de Mercy
Metz, , France
Site Status
CHU de Nimes
Nîmes, , France
Site Status
CH La Source Onco-Hèmatologie
Orléans, , France
Site Status
Hopital Saint Louis
Paris, , France
Site Status
Groupe Hospitalier Pitié- Salpétrière
Paris, , France
Site Status
CH Perpignan - Hopital Saint-Jean
Perpignan, , France
Site Status
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Site Status
Centre Hospitalier de la Region d'Annecy
Pringy, , France
Site Status
CHRU Hopital sud Medecine Interne
Rennes, , France
Site Status
Centre Hospitalier Yves Le Foll
Saint-Brieuc, , France
Site Status
Hopital civil
Strasbourg, , France
Site Status
CHRU Hôpital de Hautepierre
Strasbourg, , France
Site Status
Institut Universitaire du Cancer IUCT - Oncopole
Toulouse, , France
Site Status
CHRU Hopital BretonneauOnco-hematologie
Tours, , France
Site Status
CHRU Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
Site Status
Laiko General Hospital of Athens
Athens, , Greece
Site Status
Alexandra General Hospital of Athens
Athens, , Greece
Site Status
University of Patras
Pátrai, , Greece
Site Status
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Site Status
Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Site Status
Spedali Civili Brescia
Brescia, , Italy
Site Status
Ospedale Ferrarotto
Catania, , Italy
Site Status
Clinica Ematologica, A.O.U. San Martino di Genova
Genova, , Italy
Site Status
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
Lecce, , Italy
Site Status
Unità Operativa di Oncoematologia, Ospedale di Matera
Matera, , Italy
Site Status
U.O. di Ematologia e Trapianto di Midollo Osseo
Milan, , Italy
Site Status
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, Campania, , Italy
Site Status
Policlinico San Matteo Universita Di Pavia
Pavia, , Italy
Site Status
Ospedale Civile di Piacenza
Piacenza, , Italy
Site Status
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Site Status
Policlinico Umberto I
Roma, , Italy
Site Status
Ospedale Sant'Eugenio
Rome, , Italy
Site Status
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Site Status
Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospe
Torino, , Italy
Site Status
Ospedale Umberto I
Torrette Di Ancona, , Italy
Site Status
A.O. Universitaria Fondazione Macchi
Varese, , Italy
Site Status
Hospital Sant Pau
Barcelona, , Spain
Site Status
Hospital Clinic Provincial de Barcelona
Barcelona, , Spain
Site Status
Hospital virgen de la Arrixaca
El Palmar (murcia), , Spain
Site Status
Hospital Virgenes de las Nieves
Granada, , Spain
Site Status
Hospital La Princesa
Madrid, , Spain
Site Status
Hospital Costa del Sol
Marbella, , Spain
Site Status
Hospital Central de Asturias
Oviedo, , Spain
Site Status
Clinica Universitaria de Navarra
Pamplona, , Spain
Site Status
Hospital Universitario de Salamanca
Salamanca, , Spain
Site Status
Complejo Hospitalario de Santiago
Santiago de Compostela, , Spain
Site Status
Countries
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Belgium
France
Greece
Italy
Spain
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Gambella M, Omede P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
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CC-5013-MM-026
Identifier Type: -
Identifier Source: org_study_id
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