AzTrials
AzTrials

Multiple MyelomaPhase 3ARUMMNCT02112175

Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM

A Phase 3 study testing Lenalidomide in people with Multiple Myeloma, run by Celgene at 73 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
73 sitesin 5 countries
Study dates
30 Apr 2014to 12 Oct 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • Related to initial diagnosis and prior Melphalan Prednisone Velcade (MPV) induction therapy
  • Previously untreated and symptomatic multiple myeloma.
  • All 3 criteria (Durie, 2003) and at least one of the Creatinine Renal insufficiency Anemia lytic Bone lesions or osteoporosis criteria must be met.
  • Measurable disease by protein electrophoresis analyses.
  • 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.
Show all 24Show fewer
  • 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.
  • 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
  • Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures,
  • Age ≥ 65 years: if < 65 years of age, the subject must be non eligible for stem cell transplantation,
  • Eastern Cooperative Oncology Group performance status score ≤ 2,
  • Able to adhere to the study visit schedules and other protocol requirements,
  • Females of Childbearing Potential must:
  • 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.
  • 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.
  • Male Subjects must:
  • 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.
  • Agree to not donate semen during Investigational Product therapy and for 28 days after end of study therapy.
  • All subjects must:
  • Have an understanding that the study medication could have a potential teratogenic risk.
  • Agree to abstain from donating blood while taking Investigational Product therapy and following discontinuation of Investigational Product therapy.
  • Agree not to share study medication with another person.
  • All female of childbearing potential and male subjects must be counseled about pregnancy precautions and risks of fetal exposure.

Who cannot join

  • The presence of any of the following will exclude the subject from the study enrollment:
  • 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]).
  • 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.
  • Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or desoxyribonucleic acid modulating agents. Subjects who received investigational agents are also excluded.
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Show all 20Show fewer
  • Pregnant or lactating females.
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count < 1,000/L (1.0 x 109/L) Untransfused platelet count < 50,000 cells/L (50 x 109/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
  • Renal insufficiency (creatinine clearance < 30 mL/min by Cockcroft-Gault method) or actual creatinine clearance result, or renal failure requiring hemodialysis or peritoneal dialysis.
  • Prior history of malignancies including skin cancer, other than multiple myeloma.
  • Prior history of deep venous thrombosis or pulmonary embolus within 3 years of randomization.
  • Subjects who are unable or unwilling to undergo anti-thrombotic therapy.
  • Peripheral neuropathy of > Grade 2 severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.
  • Known Human Immunodeficiency Virus positivity or active infectious hepatitis, type A, B, or C.
  • Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis.
  • Prior allogeneic or autologous stem cell transplantation.
  • 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
  • Any condition that confounds the ability to interpret data from the study.

Trial locations and contacts

73 sites in 5 countries.

73 sites in 5 countries

France35 sites

  • CH Argenteuil Victor DupouyHematologie

    Argenteuil, 95100

  • Centre Hospitalier de la cote basque

    Bayonne, 64109

  • Hopital Jean Minjoz Hematologie

    Besançon, 25000

  • Centre Hospitalier de Blois

    Blois, 41016

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Hopital de Fleyriat

    Bourg-en-Bresse, 01012

  • Hopital A. MorvanHematologie

    Brest, 29609

  • CHU de la cote de Nacre

    Caen, 14000

  • CHRU - Hotel Dieu

    Clemont-Ferrand Cedex, 63003

  • Chu Estaing

    Clermont-Ferrand, 63000

  • Centre Hospitalier Sud Francilien - Site Gilles de Corbeil

    Corbeil-Essonnes, 91106

  • Hopital Henri Mondor

    Créteil, 94010

  • Centre Hospitalier

    Dunkirk, 59385

  • CHD Vendee

    La Roche-sur-Yon, 85000

  • CH Hematologie

    Le Chesnay, 78157

  • Kremlin Bicetre

    Le Kremlin-Bicêtre, 942975

  • Centre Jean BernardOnco-Hematologie

    Le Mans, 72000

  • Centre Hospitalier Medecine interne

    Le Mans, 72037

  • CHRU Hopital Claude Huriez

    Lile Cedax, 59037

  • CH - Hôpital Dupuytren

    Limoges, 87042

  • Centre Hospitalier Regional Metz-Thionville Hopital de Mercy

    Metz, 57038

  • CHU de Nimes

    Nîmes, 30029

  • CH La Source Onco-Hèmatologie

    Orléans, 45000

  • Hopital Saint Louis

    Paris, 75010

  • Groupe Hospitalier Pitié- Salpétrière

    Paris, 75651

  • CH Perpignan - Hopital Saint-Jean

    Perpignan, 66046

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier de la Region d'Annecy

    Pringy, 74374

  • CHRU Hopital sud Medecine Interne

    Rennes, 35056

  • Centre Hospitalier Yves Le Foll

    Saint-Brieuc, 22027

  • Hopital civil

    Strasbourg, 67091

  • CHRU Hôpital de Hautepierre

    Strasbourg, 67098

  • Institut Universitaire du Cancer IUCT - Oncopole

    Toulouse, 31059

  • CHRU Hopital BretonneauOnco-hematologie

    Tours, 37044

  • CHRU Hôpitaux de Brabois

    Vandœuvre-lès-Nancy

Other trials in France

Italy17 sites

  • Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • Spedali Civili Brescia

    Brescia, 25123

  • Ospedale Ferrarotto

    Catania, 95124

  • Clinica Ematologica, A.O.U. San Martino di Genova

    Genova, 16132

  • Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

    Lecce, 73100

  • Unità Operativa di Oncoematologia, Ospedale di Matera

    Matera, 75100

  • U.O. di Ematologia e Trapianto di Midollo Osseo

    Milan, 20132

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

    Napoli, Campania, 80131

  • Policlinico San Matteo Universita Di Pavia

    Pavia, 27100

  • Ospedale Civile di Piacenza

    Piacenza, 29100

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Policlinico Umberto I

    Roma, 00161

  • Ospedale Sant'Eugenio

    Rome, 00144

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospe

    Torino, 10126

  • Ospedale Umberto I

    Torrette Di Ancona, 60020

  • A.O. Universitaria Fondazione Macchi

    Varese, 21100

Other trials in Italy

Spain10 sites

  • Hospital Sant Pau

    Barcelona, 08025

  • Hospital Clinic Provincial de Barcelona

    Barcelona, 08036

  • Hospital virgen de la Arrixaca

    El Palmar (murcia), 30120

  • Hospital Virgenes de las Nieves

    Granada, 18014

  • Hospital La Princesa

    Madrid, 28006

  • Hospital Costa del Sol

    Marbella, 29603

  • Hospital Central de Asturias

    Oviedo, 33006

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Complejo Hospitalario de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Belgium7 sites

  • Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour

    Baudour, 7331

  • AZ-VUB

    Brussels, 1090

  • Grand Hopital de Charleroi

    Charleroi, 6000

  • Universitair Ziehenhuis Antwerpen

    Edegem, 2650

  • Centre Hospitalier de Jolimont-Lobbes

    La Louvière-(Haine St-Paul), 7100

  • AZ Nikolaas

    Sint-Niklaas, 9100

  • Cliniques Universitaires UCL de Mont-Godine

    Yvoir, 5530

Other trials in Belgium

Greece4 sites

  • Laiko General Hospital of Athens

    Athens, 11527

  • Alexandra General Hospital of Athens

    Athens, 11528

  • University of Patras

    Pátrai, 26500

  • Theagenio Anticancer Hospital of Thessaloniki

    Thessaloniki, 540 07

Other trials in Greece

About this study

Official title: Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma

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.

Read the detailed description

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.

Being tested
Lenalidomide
Keywords
Multiple Myeloma, Lenalidomide, Revlimid, MPV, Melphalan, Prednisone, Velcade, Placebo
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02112175
Study groupRoleWhat they receive
LenalidomideExperimentalTreatment Arm A: lenalidomide 10 mg/day orally from Days 1 to 21; given in 28-day cycles for up to disease progression.
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Approximately 6 years

Secondary outcomes (1)

  1. Safety; Adverse Events (AE) [type, frequency, and severity of AEs, and relationship of AEs to investigational product (IP) SAEs, laboratory abnormalities, hospitalizations, and SPMs

    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.

    Measured: Approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study start30 Apr 2014
  3. Primary completion12 Oct 2020
  4. Study completion12 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112175
Sponsor's protocol ID
CC-5013-MM-026
Acronym
ARUMM
Status last verified
Apr 2021
First submitted
9 Apr 2014
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29980678

  • 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.

    PubMed 29784907

  • 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.

    PubMed 30244101

  • 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.

    PubMed 30561775

  • 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.

    PubMed 30859608

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide in people with Multiple Myeloma, run by Celgene at 73 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in France, Italy, Spain, Belgium, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Approximately 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112175, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in