Multiple MyelomaNCT03106324
A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
An observational study of Multiple Myeloma, run by Celgene at 125 sites in 12 countries.
Trial summary
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… 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?
- Revlimid (lenalidomide)
- How many people
- 911 participants
- Where
- 125 sitesin 12 countries
- Study dates
- 31 Mar 2017to 14 Jan 2026
- How long will I take part?
- 8 Years
- Phase
- Observational
- 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
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.
Who may be able to join
- Must have understood and voluntarily signed the Informed Consent Form (ICF)
- Age ≥ 18 years at the time of signing the ICF
- Newly diagnosed with multiple myeloma
- Must not be eligible for transplant
- 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.
Who cannot join
- 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.
- 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
- 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
- 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.
Trial locations and contacts
125 sites in 12 countries.
125 sites in 12 countries
Germany30 sites
W8 Praxis für Onkologie
Aachen, 52064
Klinikum St. Marien Amberg
Amberg, 92224
Sozialstiftung Bamberg
Bamberg, 96040
Charité - Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, 10117
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200
Kliniken Berlin Köpenick
Berlin, 12559
HELIOS Klinikum Berlin Buch
Berlin, 13125
Gemeinschaftpraxis Pott/Tirier/Hannig
Bottrop, 46236
Onkologie Koln
Cologne, 50677
Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover
Deggendorf, 94469
St. Bernward Krankenhaus GmbH
Hildesheim, 31134
Stadt. Krankenhaus Kiel, 2.med Klinik,
Kiel, 24116
Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie
Krefeld, 47805
MVZ Mitte - Onkologische Schwerpunktpraxis
Leipzig, 4103
Lübecker Onkologische Schwerpunktpraxis
Lübeck, 23562
Klinikum Magdeburg
Magdeburg, 39130
Internistische Facharztzentrum mit Dialyse
Memmingen, 87700
Onko-Log Mulheim Gbr
Mülheim, 454680
Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH
München, D-80639
Stauferklinikum
Mutlangen, 73557
Klinikum Nord, Klinik für Innere Medizin 5
Nuremberg, 90419
Onkologische Praxis Oldenburg
Oldenburg, 26121
Kreiskliniken Reutlingen
Reutlingen, 72764
Das Diak
Schwäbisch Hall, 74523
Klinikum Sindelfingen, Med.Klinik I
Sindelfingen, 71065
Onkologicum Stuttgart
Stuttgart, 70174
Ueboroertliche Berugsausuebungsgemeinschaft
Troisdorf, 53840
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, 78052
Lahn-Dill-Kliniken
Wetzlar, 35578
Hämatologie / Internistische Onkologie
Wiesbaden, 65189
Italy30 sites
Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL
Allessandria, 15121
Centro di Riferimento Oncologico di Aviano
Avianno, 33081
UO di Ematologia Osp. Mons Di Miccolis
Barletta, 76121
Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna
Bologna, 40138
UO di Ematologia Osp. Perrino
Brindisi, 72100
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, 21052
"S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche
Cagliari, 0-9121
Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano
Caserta, 81100
AO Garibaldi Catania - Via Palermo 636
Catania, 95122
AO Garibaldi Catania
Catania, 95122
Ospedale di Ivrea
Chivasso, Corso Galileo Ferraris, 3 Chivasso, 10034
Ospedale Ivrea , Areas Medica
Ivrea, 10015
Ospedale dell'Angelo
Mestre, 30121
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Opsedale di Bolzano
Milan, 39100
ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -
Milan, 20162
Ospedale Maggiore di Novara
Novara, 28100
UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro
Nuoro, 8100
IRCCS Policlinico di Pavia
Pavia, 27100
UO di Ematologia Osp. S. Carlo - Potenza
Potenza, 85100
Servizio immunoematologia e medicina trasfusionale-ASP
Ragusa, 97100
S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate
Reggio Emilia, 42123
A.O Bianchi Melacrino Morelli - Presidio Riuniti
Regio Calabria, 89125
Ospedale Sant'Eugenio
Rome, 00-144
Policlinico Gemelli Roma
Rome, 00-168
UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita
Rome, 153
Ospedale di Circolo, Fondazione Macchi
Varese, 21100
Ospdeale Policlinico Borgo Roma
Verona, 37134
Ospedale Belcolle Viterbo
Viterbo, 1100
France13 sites
Hôpital privé d'Antony - Ramsay Générale de Santé
Antony, 92160
CH Victor Dupouy
Argenteuil, 95100
Polyclinique Bordeaux Nord Aquaitaine
Bordeaux, 33300
Hospital Prive Sevigne
Cesson-Sévigné, 35510
GHM Institut Daniel Hollard
Grenoble, 38000
Clinique Victor Hugo
Le Mans, 72015
CH de Libourne
Libourne, 33505
CH Mont de Marsan
Mont-de-Marsan, 40000
CHU de Nice
Nice, O6200
CHR Orleans
Orléans, 45100
CH St Jean
Perpignan, 66093
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Etienne, 42270
Hospital Prive de Villeneuve d'Ascq
Villeneuve-d'Ascq, 59650
United Kingdom13 sites
Northern Health and Social Care Trust -Antrim Area Hospital
Antrim, BT41 2RL
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, BT16 1RH
Birmingham Heartlands Hospital
Birmingham, B9 5SS,
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ
Southmead Hospital -North Bristol NHS Trust
Bristol, BS10 5NB
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
Cosham, PO6 3LY
Lincoln County Hospital
Lincoln, LN2 5QY
The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital
Liverpool, L9 7AL
St Georges Hospital
London, SW17 0QT
Norfolk and Norwich University Hospital
Norfolk, NR4 7UY
Southend Hospital
Southend-on-Sea, SS0 0RY
Royal Stoke Hospital
Stoke-on-Trent, ST4 6QG
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, WR5 1DD
Belgium12 sites
CHU Saint-Pierre
Brussels, 1000
Cliniques Universitaires Saint-Luc
Brussels, 1200
CHU-Charleroi
Brussels, 6110
CHU-Charleroi
Charleroi, 6042
UZ Gent
Ghent, 9000
AZ Groeninge
Kortijk, 8500
CHR Citadelle Liège
Liège, 4000
Ziekehuis Oost Limburg
Limbourg, 3600
CHU Ambroise Pare
Mons, 7000
AZ Nikolaas
Sint Niklass, 9100
CHPLT Verviers
Verviers, 4800
CHU du Mont-Godinne
Yvoir, 5530
Spain9 sites
Hospital de Jerez
Cadiz, 11408
Hospital Santa Lucía
Cartagena, 30202
Hospital de Jaen
Jaén, 23007
IP HULA
Lugo, 27004
Hospital Universitario Quironsalud Madrid
Madrid, 28223
Hospital Universitario Central Asturias
Oviedo, 33011
Son Espases
Palma de Mallorca, 0-7120
Complejo Universitario Navarra
Pamplona, 31008
Hospital Manises
Valencia, 46940
Netherlands8 sites
Rode Kruis Hospital
Beverwijk, 1942 LE
Nij Smellinghe
Drachten, 9202 NN
Catharina Hospital, Hemato-Oncology
Eindhoven, 5623 EJ
Admiraal de Ruyter Hospital
Goes, 4462 RA
Röpcke-Zweers Hospital
Hardenberg, 7772 SE
Academic Hospital Maastricht
Maastricht, 3526 KV
University Medical Center Utrecht
Utrecht, 3584 CX
VieCuri Medical Center
Venlo, 5912 BL
Austria3 sites
Innsbruck University Hospital
Innsbruck, A-6020
LKH Hochsteiermark
Leoben, A-8700
University hospital St. Pölten
Pölten, A-3100
Denmark2 sites
Aalborg University Hospital
Aalborg, 9100
Odense Hospital
Odense, 115000
Ireland2 sites
Midlands Regional Hospital , Hematology/Oncology
Country Offaly, R35 NY51
Waterford Regional Hospital, Waterford
Waterford, X91 ER8E
Norway2 sites
Helse Førde HF sentralsjukehuset
Førde, 6807
Akershus universitetssykehus HF
Lørenskog, 1478
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Revlimid (lenalidomide)
- Keywords
- Multiple Myeloma, Non transplant eligible, Revlimid, PASS, Non-interventional, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revlimid (lenalidomide)Drug
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Revlimid (lenalidomide) | |
| 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 Receives: Drug: Revlimid (lenalidomide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiovascular events
Number of participants with cardiovascular adverse events
Measured: Approximately 8 years
Secondary outcomes (3)
Incidence of renal impairment in NDMM patients
To document renal function among TNE NDMM patients treated with a first-line regimen
Measured: Approximately 8 years
Incidence of infections in NDMM patients
To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
Measured: Approximately 8 years
Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen
Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.
Measured: Approximately 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start31 Mar 2017
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 911 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, MD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106324
- Sponsor's protocol ID
- CC-5013-MM-034
- Other IDs
- U1111-1194-5810
- Status last verified
- May 2026
- First submitted
- 29 Mar 2017
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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])
- ClinicalTrials.gov ID
- NCT03106324
- Acronym / sponsor ID
- CC-5013-MM-034
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Non transplant eligible, Revlimid, PASS, Non-interventional, Lenalidomide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNE NDMM patients treated with lenalidomide regimen | – | Drug: Revlimid (lenalidomide)Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen containing lenalidomide |
| TNE NDMM patients treated with non-lenalidomide | – | Drug: Revlimid (lenalidomide)Newly diagnosed multiple myeloma patients who are not eligible for transplant and who are treated with a first-line regimen not containing lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Must have understood and voluntarily signed the Informed Consent Form (ICF)
- Age ≥ 18 years at the time of signing the ICF
- Newly diagnosed with multiple myeloma
- Must not be eligible for transplant
- 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.
Key exclusion criteria (4 listed)
- 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.
- 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
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revlimid (lenalidomide)Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice | Drug | TNE NDMM patients treated with lenalidomide regimen, TNE NDMM patients treated with non-lenalidomide |
Primary outcome
Incidence of cardiovascular events
Time frame: Approximately 8 years
Number of participants with cardiovascular adverse events
3 secondary outcomes
Incidence of renal impairment in NDMM patients
Time frame: Approximately 8 years
Incidence of infections in NDMM patients
Time frame: Approximately 8 years
Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen
Time frame: Approximately 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb, MD study director
Bristol-Myers Squibb
125 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene at 125 sites in 12 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 5 inclusion and 4 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in Germany, Italy, France, United Kingdom, Belgium and 7 more countries. 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.
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?
Incidence of cardiovascular events (time frame: Approximately 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.