Multiple MyelomaPhase 3KarMMa-9NCT06045806
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
A Phase 3 study testing idecabtagene vicleucel, Lenalidomide and Fludarabine in people with Multiple Myeloma, run by Celgene at 101 sites in 18 countries.
Trial summary
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). 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?
- idecabtagene vicleucel, Lenalidomide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 101 sitesin 18 countries
- Study dates
- 16 Oct 2023to 20 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
- Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
- Participant must have documented response of PR or VGPR at time of consent.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
- Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Who cannot join
- Participant with known central nervous system involvement with myeloma.
- Participant has non-secretory MM.
- Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
- Participant has history of primary immunodeficiency.
- Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
101 sites in 18 countries.
101 sites in 18 countries
United States20 sites
Local Institution - 0121
Atlanta, Georgia, 30322
Local Institution - 0104
Atlanta, Georgia, 30342
Local Institution - 0124
Austin, Texas, 78704
Local Institution - 0151
Boston, Massachusetts, 02215
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, 28204
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Local Institution - 0109
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Local Institution - 0131
Los Angeles, California, 90095
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
Yale University School of Medicine
New Haven, Connecticut, 06510
Columbia University Irving Medical Center
New York, New York, 10032
Local Institution - 0126
Orange, California, 92868
AdventHealth Orlando
Orlando, Florida, 32804
Local Institution - 0132
Philadelphia, Pennsylvania, 19104
Local Institution - 0113
Sacramento, California, 95817
Ascension Providence Hospital
Southfield, Michigan, 48075
Washington University School of Medicine
St Louis, Missouri, 63108
Washington University School of Medicine
St Louis, Missouri, 63110
France11 sites
Henri Mondor Hospital
Créteil, Val-de-Marne, 94010
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59000
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, 13273
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, 44000
Local Institution - 0082
Paris, 75010
Local Institution - 0031
Paris, Île-de-France Region, 75571
Local Institution - 0047
Pessac, Aquitaine, 33600
Local Institution - 0046
Pierre-Bénite, Rhône, 69310
Local Institution - 0029
Poitiers, Vienne, 86021
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, 31100
Local Institution - 0028
Villejuif, Val-de-Marne, 94805
Japan10 sites
Chiba University Hospital
Chiba, 260-8677
Kyushu University Hospital
Fukuoka, 812-8582
Local Institution - 0085
Isehara, Kanagawa, 259-1193
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Okayama University Hospital
Okayama, 700-8558
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935
Local Institution - 0071
Shimotsuke, 329-0498
Germany9 sites
Local Institution - 0073
Cologne, North Rhine-Westphalia, 50937
Local Institution - 0079
Dresden, 01307
Local Institution - 0115
Essen, 45122
Local Institution - 0076
Hamburg, 20246
Local Institution - 0072
Heidelberg, Baden-Wurttemberg, 69120
Local Institution - 0087
Leipzig, Saxony, 04103
Local Institution - 0077
Nuremberg, Bavaria, 90419
Local Institution - 0078
Ulm, Baden-Wurttemberg, 89081
Local Institution - 0074
Würzburg, 97080
Spain7 sites
Local Institution - 0020
Badalona, Barcelona [Barcelona], 08916
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036
Local Institution - 0017
L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908
Local Institution - 0021
Madrid, 28041
Local Institution - 0012
Pamplona, Navarre, 31008
Local Institution - 0013
Salamanca, 37007
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Australia6 sites
Local Institution - 0005
Brisbane, Queensland, 4029
Local Institution - 0007
Camperdown, New South Wales, 2050
Local Institution - 0004
Melbourne, Victoria, 3000
Local Institution - 0006
Melbourne, Victoria, 3004
Local Institution - 0008
Melbourne, Victoria, 3065
Local Institution - 0011
Murdoch, Western Australia, 6150
Israel6 sites
Local Institution - 0055
Beersheba, Southern District, 8410101
Local Institution - 0056
Haifa, 31096
Local Institution - 0059
Jerusalem, 9112001
Local Institution - 0058
Petah Tikva, Central District, 4910021
Local Institution - 0057
Ramat Gan, Central District, 5262100
Local Institution - 0088
Tel Aviv, Tell Abīb, 6423906
Poland6 sites
Local Institution - 0026
Gdansk, 80-952
Local Institution - 0022
Gliwice, Silesian Voivodeship, 44-101
Local Institution - 0027
Lublin, Lublin Voivodeship, 20-090
Local Institution - 0024
Poznan, 60-569
Local Institution - 0095
Warsaw, Masovian Voivodeship, 02-097
Local Institution - 0023
Warsaw, Masovian Voivodeship, 02-776
South Korea5 sites
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, 58128
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Local Institution - 0038
Seoul, Seoul Teugbyeolsi, 06351
Local Institution - 0043
Seoul, Seoul Teugbyeolsi, 06591
Asan Medical Center
Seoul, Seoul-teukbyeolsi, 05505
Greece4 sites
Local Institution - 0061
Athens, Attikí, 106 76
Local Institution - 0062
Chaïdári, Attikí, 12462
Local Institution - 0063
Pátrai, Achaḯa, 26504
Local Institution - 0060
Thessaloniki, Thessaloníki, 570 10
Belgium3 sites
Local Institution - 0083
Anderlecht, Bruxelles-Capitale, Région de, 1070
Local Institution - 0084
Brussels, Bruxelles-Capitale, Région de, 1090
Local Institution - 0144
Brussels, Bruxelles-Capitale, Région de, 1200
Canada3 sites
Local Institution - 0133
Edmonton, Alberta, T6G 1Z2
Local Institution - 0001
Hamilton, Ontario, L8V5C2
Local Institution - 0134
Montreal, Quebec, H1T 2M4
Italy3 sites
Local Institution - 0065
Bologna, 40138
Local Institution - 0066
Roma, 00161
Local Institution - 0064
Rozzano, Milano, 20089
United Kingdom3 sites
Local Institution - 0093
Birmingham, England, B15 2TH
Local Institution - 0080
London, London, City of, SE5 9RS
Local Institution - 0094
London, London, City of, W12 0HS
Austria2 sites
Local Institution - 0089
Salzburg, 5020
Local Institution - 0090
Vienna, 1090
About this study
Official title: A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
- Conditions
- Multiple Myeloma
- Being tested
- idecabtagene vicleucel, Lenalidomide, Fludarabine, Cyclophosphamide
- Keywords
- CAR-T
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
idecabtagene vicleucelBiological
Also called BMS-986395, Abecma, bb2121, ide-cel
Specified dose on specified days
LenalidomideDrug
Also called Revlimid, LEN
Specified dose on specified days
FludarabineDrug
Also called FLUDARA, BENDARBIN
Specified dose on specified days
CyclophosphamideDrug
Also called ENDOXAN, CYTOXAN
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Biological: idecabtagene vicleucel; Drug: Lenalidomide; Drug: Fludarabine; Drug: Cyclophosphamide |
| Arm B | Active comparator | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS as assessed by Independent Review Committee (IRC)
Measured: Up to approximately 50 months after the first participant is randomized
Secondary outcomes (18)
Overall Survival (OS)
Measured: Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
Measured: From randomization up to 60 months from randomization
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Measured: From randomization up to 15 months from randomization
Event-Free Survival (EFS)
Measured: Up to approximately 60 months after the last participant is randomized
Duration of Response (DOR)
Measured: Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Complete Response (CR)
CR as assessed by IRC
Measured: Up to approximately 60 months after the last participant is randomized
Time to Progression (TTP)
Progression as assessed by IRC
Measured: Up to approximately 60 months after the last participant is randomized
Progression post-next line of treatment (PFS2)
Measured: Up to approximately 60 months after the last participant is randomized
Time to Next Treatment (TTNT)
Measured: Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Measured: Up to approximately 60 months after the last participant is randomized
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to approximately 60 months after the last participant is randomized
Time of Maximum Observed Plasma Concentration (Tmax)
Measured: Up to approximately 60 months after the last participant is randomized
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
Measured: Up to 28 days post infusion
Time of Last Measurable Observed Plasma Concentration (Tlast)
Measured: Up to approximately 60 months after the last participant is randomized
Time-to-Definitive Deterioration
Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
Measured: Up to approximately 50 months after the first participant is randomized
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed:
- Global health status/quality of life
- Physical Functioning
- Fatigue
- Pain
Measured: Up to approximately 50 months after the first participant is randomized
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed:
- Disease symptoms
- Side-effects of treatment
Measured: Up to approximately 50 months after the first participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start16 Oct 2023
- Primary completion11 Aug 2025
- Study completion20 Nov 2029 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, 2seventy bio
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045806
- Sponsor's protocol ID
- CA089-1043
- Other IDs
- 2022-501346-30, U1111-1280-9736
- Acronym
- KarMMa-9
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
- ClinicalTrials.gov ID
- NCT06045806
- Acronym / sponsor ID
- KarMMa-9 / CA089-1043
- Conditions
- Multiple Myeloma
- Keywords
- CAR-T
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, 2seventy bio
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 20 Nov 2029 (estimated)
- First posted
- 21 Sep 2023 (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.
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: idecabtagene vicleucel, Drug: Lenalidomide, Drug: Fludarabine, Drug: Cyclophosphamide |
| Arm B | Active comparator | Drug: Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
- Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
- Participant must have documented response of PR or VGPR at time of consent.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
- Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Key exclusion criteria (6 listed)
- Participant with known central nervous system involvement with myeloma.
- Participant has non-secretory MM.
- Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
- Participant has history of primary immunodeficiency.
- Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
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 |
|---|---|---|
| idecabtagene vicleucelAlso: BMS-986395, Abecma, bb2121, ide-celSpecified dose on specified days | Biological | Arm A |
| LenalidomideAlso: Revlimid, LENSpecified dose on specified days | Drug | Arm A, Arm B |
| FludarabineAlso: FLUDARA, BENDARBINSpecified dose on specified days | Drug | Arm A |
| CyclophosphamideAlso: ENDOXAN, CYTOXANSpecified dose on specified days | Drug | Arm A |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to approximately 50 months after the first participant is randomized
PFS as assessed by Independent Review Committee (IRC)
18 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
Time frame: From randomization up to 60 months from randomization
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Time frame: From randomization up to 15 months from randomization
Event-Free Survival (EFS)
Time frame: Up to approximately 60 months after the last participant is randomized
Duration of Response (DOR)
Time frame: Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Complete Response (CR)
Time frame: Up to approximately 60 months after the last participant is randomized
Time to Progression (TTP)
Time frame: Up to approximately 60 months after the last participant is randomized
Progression post-next line of treatment (PFS2)
Time frame: Up to approximately 60 months after the last participant is randomized
Time to Next Treatment (TTNT)
Time frame: Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Time frame: Up to approximately 60 months after the last participant is randomized
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to approximately 60 months after the last participant is randomized
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to approximately 60 months after the last participant is randomized
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
Time frame: Up to 28 days post infusion
Time of Last Measurable Observed Plasma Concentration (Tlast)
Time frame: Up to approximately 60 months after the last participant is randomized
Time-to-Definitive Deterioration
Time frame: Up to approximately 50 months after the first participant is randomized
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
Time frame: Up to approximately 50 months after the first participant is randomized
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
Time frame: Up to approximately 50 months after the first participant is randomized
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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 study director
Bristol-Myers Squibb
101 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing idecabtagene vicleucel, Lenalidomide and Fludarabine in people with Multiple Myeloma, run by Celgene at 101 sites in 18 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 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, France, Japan, Germany, Spain and 13 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
Progression Free Survival (PFS) (time frame: Up to approximately 50 months after the first participant is randomized). 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 5 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.