A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant

May 25, 2026 updated by: Celgene

A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])

This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
911

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Innsbruck University Hospital
      • Leoben, Austria, A-8700
        • LKH Hochsteiermark
      • Pölten, Austria, A-3100
        • University hospital St. Pölten
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • CHU Saint-Pierre
      • Brussels, Belgium, 6110
        • CHU-Charleroi
      • Charleroi, Belgium, 6042
        • CHU-Charleroi
      • Ghent, Belgium, 9000
        • UZ Gent
      • Kortijk, Belgium, 8500
        • AZ Groeninge
      • Limbourg, Belgium, 3600
        • Ziekehuis Oost Limburg
      • Liège, Belgium, 4000
        • CHR Citadelle Liège
      • Mons, Belgium, 7000
        • CHU Ambroise Pare
      • Sint Niklass, Belgium, 9100
        • AZ Nikolaas
      • Verviers, Belgium, 4800
        • CHPLT Verviers
      • Yvoir, Belgium, 5530
        • CHU du Mont-Godinne
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg University Hospital
      • Odense, Denmark, 115000
        • Odense Hospital
  • France
      • Antony, France, 92160
        • Hôpital privé d'Antony - Ramsay Générale de Santé
      • Argenteuil, France, 95100
        • CH Victor Dupouy
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Aquaitaine
      • Cesson-Sévigné, France, 35510
        • Hospital Prive Sevigne
      • Grenoble, France, 38000
        • GHM Institut Daniel Hollard
      • Le Mans, France, 72015
        • Clinique Victor Hugo
      • Libourne, France, 33505
        • CH de Libourne
      • Mont-de-Marsan, France, 40000
        • CH Mont de Marsan
      • Nice, France, O6200
        • CHU de Nice
      • Orléans, France, 45100
        • CHR ORLEANS
      • Perpignan, France, 66093
        • CH St Jean
      • Saint-Etienne, France, 42270
        • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
      • Villeneuve-d'Ascq, France, 59650
        • Hospital Prive de Villeneuve d'Ascq
  • Germany
      • Aachen, Germany, 52064
        • W8 Praxis für Onkologie
      • Amberg, Germany, 92224
        • Klinikum St. Marien Amberg
      • Bamberg, Germany, 96040
        • Sozialstiftung Bamberg
      • Berlin, Germany, 12200
        • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin Buch
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin - Campus Charité Mitte
      • Berlin, Germany, 12559
        • Kliniken Berlin Köpenick
      • Bottrop, Germany, 46236
        • Gemeinschaftpraxis Pott/Tirier/Hannig
      • Cologne, Germany, 50677
        • Onkologie Koln
      • Deggendorf, Germany, 94469
        • Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
      • Hildesheim, Germany, 31134
        • St. Bernward Krankenhaus GmbH
      • Kiel, Germany, 24116
        • Stadt. Krankenhaus Kiel, 2.med Klinik,
      • Krefeld, Germany, 47805
        • Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
      • Leipzig, Germany, 4103
        • MVZ Mitte - Onkologische Schwerpunktpraxis
      • Lübeck, Germany, 23562
        • Lübecker Onkologische Schwerpunktpraxis
      • Magdeburg, Germany, 39130
        • Klinikum Magdeburg
      • Memmingen, Germany, 87700
        • Internistische Facharztzentrum mit Dialyse
      • Mutlangen, Germany, 73557
        • Stauferklinikum
      • Mülheim, Germany, 454680
        • Onko-Log Mulheim Gbr
      • München, Germany, D-80639
        • Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
      • Nuremberg, Germany, 90419
        • Klinikum Nord, Klinik für Innere Medizin 5
      • Oldenburg, Germany, 26121
        • Onkologische Praxis Oldenburg
      • Reutlingen, Germany, 72764
        • Kreiskliniken Reutlingen
      • Schwäbisch Hall, Germany, 74523
        • Das Diak
      • Sindelfingen, Germany, 71065
        • Klinikum Sindelfingen, Med.Klinik I
      • Stuttgart, Germany, 70174
        • Onkologicum Stuttgart
      • Troisdorf, Germany, 53840
        • Ueboroertliche Berugsausuebungsgemeinschaft
      • Villingen-Schwenningen, Germany, 78052
        • Kliniken Villingen-Schwenningen
      • Wetzlar, Germany, 35578
        • Lahn-Dill-Kliniken
      • Wiesbaden, Germany, 65189
        • Hämatologie / Internistische Onkologie
  • Ireland
      • Country Offaly, Ireland, R35 NY51
        • Midlands Regional Hospital , Hematology/Oncology
      • Waterford, Ireland, X91 ER8E
        • Waterford Regional Hospital, Waterford
  • Italy
      • Allessandria, Italy, 15121
        • Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
      • Avianno, Italy, 33081
        • Centro di Riferimento Oncologico di Aviano
      • Barletta, Italy, 76121
        • UO di Ematologia Osp. Mons Di Miccolis
      • Bologna, Italy, 40138
        • Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
      • Brindisi, Italy, 72100
        • UO di Ematologia Osp. Perrino
      • Busto Arsizio, Italy, 21052
        • Ospedale di Circolo di Busto Arsizio
      • Cagliari, Italy, 0-9121
        • "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
      • Caserta, Italy, 81100
        • Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
      • Catania, Italy, 95122
        • AO Garibaldi Catania - Via Palermo 636
      • Catania, Italy, 95122
        • AO Garibaldi Catania
      • Ivrea, Italy, 10015
        • Ospedale Ivrea , Areas Medica
      • Mestre, Italy, 30121
        • Ospedale dell'Angelo
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milan, Italy, 39100
        • Opsedale di Bolzano
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
      • Novara, Italy, 28100
        • Ospedale Maggiore di Novara
      • Nuoro, Italy, 8100
        • UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro
      • Pavia, Italy, 27100
        • IRCCS Policlinico di Pavia
      • Potenza, Italy, 85100
        • UO di Ematologia Osp. S. Carlo - Potenza
      • Ragusa, Italy, 97100
        • Servizio immunoematologia e medicina trasfusionale-ASP
      • Reggio Emilia, Italy, 42123
        • S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
      • Regio Calabria, Italy, 89125
        • A.O Bianchi Melacrino Morelli - Presidio Riuniti
      • Rome, Italy, 00-144
        • Ospedale Sant'Eugenio
      • Rome, Italy, 00-168
        • Policlinico Gemelli Roma
      • Rome, Italy, 153
        • UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
      • Varese, Italy, 21100
        • Ospedale di Circolo, Fondazione Macchi
      • Verona, Italy, 37134
        • Ospdeale Policlinico Borgo Roma
      • Viterbo, Italy, 1100
        • Ospedale Belcolle Viterbo
    • Corso Galileo Ferraris, 3 Chivasso
      • Chivasso, Corso Galileo Ferraris, 3 Chivasso, Italy, 10034
        • Ospedale di Ivrea
  • Netherlands
      • Beverwijk, Netherlands, 1942 LE
        • Rode Kruis Hospital
      • Drachten, Netherlands, 9202 NN
        • Nij Smellinghe
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Hospital, Hemato-Oncology
      • Goes, Netherlands, 4462 RA
        • Admiraal de Ruyter Hospital
      • Hardenberg, Netherlands, 7772 SE
        • Röpcke-Zweers Hospital
      • Maastricht, Netherlands, 3526 KV
        • Academic Hospital Maastricht
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medical Center
  • Norway
      • Førde, Norway, 6807
        • Helse Førde HF sentralsjukehuset
      • Lørenskog, Norway, 1478
        • Akershus Universitetssykehus HF
  • Spain
      • Cadiz, Spain, 11408
        • Hospital de Jerez
      • Cartagena, Spain, 30202
        • Hospital Santa Lucía
      • Jaén, Spain, 23007
        • Hospital de Jaen
      • Lugo, Spain, 27004
        • IP HULA
      • Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
      • Oviedo, Spain, 33011
        • Hospital Universitario Central Asturias
      • Palma de Mallorca, Spain, 0-7120
        • Son Espases
      • Pamplona, Spain, 31008
        • Complejo Universitario Navarra
      • Valencia, Spain, 46940
        • Hospital Manises
  • Sweden
      • Lund, Sweden, 22185
        • Skåne University Hospital, Lund
  • United Kingdom
      • Antrim, United Kingdom, BT41 2RL
        • Northern Health and Social Care Trust -Antrim Area Hospital
      • Belfast, United Kingdom, BT16 1RH
        • South Eastern Health and Social Care Trust - The Ulster Hospital
      • Birmingham, United Kingdom, B9 5SS,
        • Birmingham Heartlands Hospital
      • Bodelwyddan, United Kingdom, LL18 5UJ
        • Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital -North Bristol NHS Trust
      • Cosham, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
      • Lincoln, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, United Kingdom, L9 7AL
        • The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
      • London, United Kingdom, SW17 0QT
        • St Georges Hospital
      • Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Southend-on-Sea, United Kingdom, SS0 0RY
        • Southend Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke Hospital
      • Worcester, United Kingdom, WR5 1DD
        • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant (TNE) starting their first treatment for multiple myeloma. Patients receiving any first line regimen can be included into the study. Decision for treatment needs to be done before inclusion into the trial.

Description

Inclusion Criteria:

  1. Must have understood and voluntarily signed the Informed Consent Form (ICF)
  2. Age ≥ 18 years at the time of signing the ICF
  3. Newly diagnosed with multiple myeloma
  4. Must not be eligible for transplant
  5. Will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles.

Exclusion Criteria:

  1. Prior treatment for Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line Multiple myeloma (MM) therapy.
  2. Prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line MM therapy through clinical trial participation or patient access program
  3. Two or more complete cycles of first-line therapy or any agent considered to be a firstline MM therapy for newly diagnosed multiple myeloma (NDMM) treatment before study enrollment
  4. Refusal to participate in the Revlimid Transplant noneligible (TNE) Newly diagnosed multiple myeloma (NDMM) Post-authorization safety study (PASS) or current participation in the treatment phase of an interventional clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TNE NDMM patients treated with lenalidomide regimen
Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide
Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
TNE NDMM patients treated with non-lenalidomide
Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide
Drug: Revlimid (lenalidomide)
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of cardiovascular events
Time Frame: Approximately 8 years
Number of participants with cardiovascular adverse events
Approximately 8 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of renal impairment in NDMM patients
Time Frame: Approximately 8 years
To document renal function among TNE NDMM patients treated with a first-line regimen
Approximately 8 years
Incidence of infections in NDMM patients
Time Frame: Approximately 8 years
To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
Approximately 8 years
Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen
Time Frame: Approximately 8 years
Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.
Approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, MD, Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-5013-MM-034
  • U1111-1194-5810 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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