Relapsed/Refractory Multiple MyelomaMoMMentNCT05160584
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
An observational study of Relapsed/Refractory Multiple Myeloma, run by Janssen Pharmaceutica N.V., Belgium at 90 sites in 12 countries.
Trial summary
The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- How many people
- 256 participants
- Where
- 90 sitesin 12 countries
- Study dates
- 18 Nov 2021to 30 Oct 2028
- Phase
- Observational
- 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
Study population: The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.
Who may be able to join
- For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
- For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
- For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
- For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
- For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
- For Period 1 and 2: Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible
Show all 10Show fewer
- For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
- Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
- For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain >= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (>=1 lesion has 2 diameters >= 1 centimeter [cm])
Who cannot join
None listed.
Trial locations and contacts
90 sites in 12 countries.
90 sites in 12 countries
Italy21 sites
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari, 70124
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, 70124
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna, 40138
Policlinico di Catania
Catania, 95128
Ospedale Civile di Civitanova Marche
Civitanova Marche, 62012
IRCCS Azienda Ospedaliera San Martino - IST
Genova, 16132
Ospedale Policlinico San Martino IRCCS
Genova, 16132
Ospedale Vito Fazzi
Lecce, 73100
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, 35128
Ospedale Villa Sofia-Cervello
Palermo, 90146
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Presidio Ospedaliero Pescara
Pescara, 65124
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
Reggio Calabria, 89124
Università di Roma La Sapienza
Roma, 00161
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
Campus Bio Medico di Roma
Roma, 128
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Ospedale Cardinale G. Panico
Tricase, 73039
Azienda Ulss 8 Berica- Ospedale Di Vicenza
Vicenza, 36100
Spain16 sites
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 08908
Hosp. de Cabuenes
Gijón, 33394
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
Hosp. de Leon
León, 24008
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. Son Espases
Palma, 7120
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Hosp. Univ. Dr. Peset
Valencia, 46017
Hosp. Clinico Univ. de Valladolid
Valladolid, 47003
Hosp. Univ. Miguel Servet
Zaragoza, 50009
Germany12 sites
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berin, 12203
Universitaetsklinikum Koeln
Cologne, 50397
Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
Dresden, 01307
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
Hamburg, 20251
St. Barbara-Klinik Hamm GmbH
Hamm, 59073
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe
MVZ Mitte-Onkologische Schwerpunktpraxis
Leipzig, 04103
Universitaetsklinikum Leipzig
Leipzig, 4103
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
Tübingen, 72076
Universitatsklinikum Wurzburg
Würzburg, 97080
Heinrich-Braun-Klinikum gGmbH
Zwickau, 08060
Greece9 sites
University Hospital of Alexandroupolis
Alexandroupoli, 68100
Henry Dunant Hospital Center
Athens, 115 26
Laiko General Hospital Of Athens 1
Athens, 115 27
Laiko General Hospital of Athens 2
Athens, 115 27
Alexandra Hospital
Athens, 115 28
Metaxa Cancer Center Hospital Of Piraeus
Piraeus, 18537
General University Hospital of Patras
Rio, 265 04
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, 546 39
Ahepa University General Hospital of Thessaloniki
Thessaloniki, 54636
United Kingdom7 sites
Southmead Hospital
Bristol, BS10 5NB
University College Hospital
London, NW1 2PG
Kings College Hospital
London, SE5 9RS
St Georges Hospital
London, SW17 OQT
Maidstone Hospital
Maidstone, ME16 9QQ
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
The Royal Marsden NHS Trust Sutton
Surrey, SM2 5PT
Belgium6 sites
UZ Antwerpen
Edegem, 2650
Ziekenhuis Oost-Limburg
Genk, 3600
UZ Leuven
Leuven, 3000
Chu Helora Hospital De Mons Site Kennedy
Mons, 7000
Vitaz
Sint-Niklaas, 9100
Ucl de Mont-Godinne
Yvoir, 5530
France5 sites
CHRU de Lille Hopital Claude Huriez
Lille, 59037
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34295
CHU de Nantes hotel Dieu
Nantes, 44093
Centre hospitalier Lyon-Sud
Pierre-Bénite, 69495
Pôle IUC Oncopole CHU
Toulouse, 31059
Switzerland4 sites
Kantonsspital Graubunden
Chur, 7000
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur, 8400
Hirslanden Klinik Hirslanden
Zurich, 8032
Universitatsspital Zurich
Zurich, 8091
Portugal3 sites
Ulstmad - Hosp. Chaves
Chaves, 5400 482
Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, 3004 561
Uls Sao Joao - Hosp. Sao Joao
Porto, 4200 319
Romania3 sites
Fundeni Clinical Institute
Bucharest, 022328
Spitalul Clinic Coltea, Clinica Hematologie
Bucharest
Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1
Cluj-Napoca, 400015
Austria2 sites
LKH Leoben
Leoben, 8700
Krankenhaus der barmherzigen Schwestern
Vienna, 1060
Netherlands2 sites
VU Medisch Centrum
Amsterdam, 1081 HV
UMCG
Groningen, 9713 GZ
About this study
Official title: A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- No intervention
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no interventional treatment component for participants with RRMM in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Relapsed/Refractory Multiple Myeloma | Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).
Measured: Up to 52 months
Secondary outcomes (20)
Very Good Partial Response (VGPR) Rate
VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.
Measured: Up to 52 months
Complete Response (CR) Rate
CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.
Measured: Up to 52 months
Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.
Measured: Up to 52 months
Minimal Residual Disease (MRD) Negative Rate
MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.
Measured: Up to 52 months
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).
Measured: Up to 52 months
Duration of Response (DOR)
DOR is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease as defined in the IMWG criteria.
Measured: Up to 52 months
Time to Response (TTR)
TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response.
Measured: Up to 52 months
Time to Best Response
Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.
Measured: Up to 52 months
Time to Next Treatment (TTNT)
TTNT is defined as the time from diagnosis to the start of the next-line treatment.
Measured: Up to 52 months
Progression-free Survival (PFS)
PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first.
Measured: Up to 52 months
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)
PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first.
Measured: Up to 52 months
Overall Survival (OS)
OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first.
Measured: Up to 52 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Baseline up to 52 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline up to 52 months
Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39
EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much).
Measured: Baseline up to 52 months
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 52 months
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.
Measured: Up to 52 months
Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
PRO-CTCAE consist of 1-8 questions of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. The following items were selected for inclusion for patients with multiple myeloma: nausea, vomiting, diarrhea, shortness of breath, rash, dizziness, headache, taste changes, and fatigue/tiredness/lack of energy.
Measured: Up to 52 months
Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)
The Epstein Taste Survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. Developed for use in patients with head and neck cancer.
Measured: Up to 52 months
Period 3: Percentage of Participants with Overall Response to Subsequent Therapies
Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC). Overall response for subsequent therapies, including BCMA-targeted therapies after treatment with talquetamab will be reported.
Measured: Up to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start18 Nov 2021
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study director, Janssen Pharmaceutica N.V., Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160584
- Sponsor's protocol ID
- CR109118
- Other IDs
- 64407564MMY4001
- Acronym
- MoMMent
- Status last verified
- Nov 2026
- First submitted
- 15 Dec 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Publications
Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.
PubMed 41313549Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
PubMed 38402374Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19.
PubMed 38110653
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05160584
- Acronym / sponsor ID
- MoMMent / CR109118
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 16 Dec 2021 (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 assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Relapsed/Refractory Multiple Myeloma | – | Other: No interventionParticipants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.
Key inclusion criteria (10 listed)
- For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
- For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
- For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
- For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
- For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No interventionThere is no interventional treatment component for participants with RRMM in this study. | Other | Participants with Relapsed/Refractory Multiple Myeloma |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 52 months
Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).
20 secondary outcomes
Very Good Partial Response (VGPR) Rate
Time frame: Up to 52 months
Complete Response (CR) Rate
Time frame: Up to 52 months
Stringent Complete Response (sCR) Rate
Time frame: Up to 52 months
Minimal Residual Disease (MRD) Negative Rate
Time frame: Up to 52 months
Clinical Benefit Rate (CBR)
Time frame: Up to 52 months
Duration of Response (DOR)
Time frame: Up to 52 months
Time to Response (TTR)
Time frame: Up to 52 months
Time to Best Response
Time frame: Up to 52 months
Time to Next Treatment (TTNT)
Time frame: Up to 52 months
Progression-free Survival (PFS)
Time frame: Up to 52 months
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)
Time frame: Up to 52 months
Overall Survival (OS)
Time frame: Up to 52 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Time frame: Baseline up to 52 months
Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Time frame: Baseline up to 52 months
Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39
Time frame: Baseline up to 52 months
Number of Participants with Adverse Events (AEs)
Time frame: Up to 52 months
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: Up to 52 months
Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to 52 months
Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)
Time frame: Up to 52 months
Period 3: Percentage of Participants with Overall Response to Subsequent Therapies
Time frame: Up to 52 months
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 3 Nov 2026.
- Derived from this study: PubMed 41313549Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.
- Derived from this study: PubMed 38402374Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.
- Derived from this study: PubMed 38110653Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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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.
Janssen Pharmaceutica N.V., Belgium Clinical Trial study director
Janssen Pharmaceutica N.V., Belgium
90 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Multiple Myeloma, run by Janssen Pharmaceutica N.V., Belgium at 90 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 10 inclusion and 0 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in Italy, Spain, Germany, Greece, United Kingdom 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?
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?
Overall Response Rate (ORR) (time frame: Up to 52 months). 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 NCT05160584, which also lists 3 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 3 Nov 2026.