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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520897-21 | Other Identifier | EUCT | |
| 2025-520897-21-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| IFM (Intergroupe Français du Myélome); PETHEMA (Program for the Study and Treatment of Haematological Malignances) | UNKNOWN |
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Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide
Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Etentamig + Daratumumab Dose A | Experimental | Participants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration. |
|
| Phase 2: Etentamig + Daratumumab Dose B | Experimental | Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration. |
|
| Phase 2: Etentamig + Daratumumab Dose C | Experimental | Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration. |
|
| Phase 3: Etentamig + Daratumumab RP3D | Experimental | Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration. |
|
| Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd) | Experimental | Participants will receive DRd, as part of the approximately 16 year study duration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etentamig | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to Approximately 16 Years |
| Phase 2: Change in Clinical Activity | Clinical activity is defined as change in response rates [Overall Response Rate (ORR), Complete Response (CR) or Better, Very Good Partial Response (VGPR), Partial Response (PR)] as determined International Myeloma Working Group (IMWG (2016). | Up to Approximately 52 weeks |
| Phase 3: Minimal Residual Disease (MRD) Negative CR Rate | MRDnegCR rate, is defined as the percentage of participants who have achieved stringent complete response (sCR) or CR as assessed by independent review committee (IRC) and have negative MRD defined at 10^-5 threshold as assessed by next generation sequencing (NGS). | Up to Approximately 52 weeks |
| Phase 3: Progression-Free Survival (PFS) | PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first. | Up to Approximately 130 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: MRD Negative CR Rate | MRDnegCR rate, is defined as the percentage of participants who have achieved sCR or CR and have negative MRD defined at 10^-5 threshold as assessed by NGS. | Up to Approximately 52 Weeks |
| Phase 2: PFS |
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Inclusion Criteria:
Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT).
IMWG Myeloma Frailty Index Score of >= 1
All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital Scottsdale /ID# 278349 | Recruiting | Scottsdale | Arizona | 85259 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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|
| Lenalidomide | Drug | Oral Capsule |
|
| Daratumumab | Drug | Subcutaneous Injection |
|
| Dexamethasone | Drug | Oral Tablet |
|
| Dexamethasone | Drug | IV Injection |
|
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.
| Up to Approximately 130 Months |
| Phase 2: Sustained MRD Negativity Rate | The rate of sustained MRD-negativity is defined as the percentage of participants with maintenance of MRD negativity status in bone marrow confirmed >=12 months apart prior to initiation of new anti-MM therapy. | Up to Approximately 12 Months |
| Phase 2: Area Under the Serum Concentration-Time Curve (AUC) | Area under the plasma concentration-time curve (AUC). | Up to Approximately 12 Months |
| Phase 2: Overall Survival (OS) | OS is defined as the duration from the date of randomization to the date of the participant's death. | Up to Approximately 16 Years |
| Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability | Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) | Up to Approximately 16 Years |
| Phase 2: Maximum Observed Serum Concentration (Cmax) | Maximum observed serum concentration (Cmax). | Up to Approximately 12 Months |
| Phase 2: Time to Cmax (Time to Maximum Observed Concentration, Tmax) | Time to Cmax. | Up to Approximately 12 Months |
| Phase 2: Positive Anti-Drug Antibodies (ADAs) | Positive ADAs. | Up to Approximately 90 days after the last dose of study treatment |
| Phase 2: Negative ADAs | Negative ADAs. | Up to Approximately 90 days after the last dose of study treatment |
| Phase 2: Neutralizing Anti-Drug Antibodies (NAbs) | Neutralizing anti-drug antibodies (NAbs). | Up to Approximately 90 days after the last dose of study treatment |
| Phase 3: OS | OS is defined as the duration from the date of randomization to the date of the participant's death. | Up to Approximately 16 Years |
| Phase 3: Sustained MRD Negativity Rate | The rate of sustained MRD-negativity is defined as the percentage of participants with maintenance of MRD negativity status in bone marrow confirmed >=12 months apart prior to initiation of new anti-MM therapy. | Up to Approximately 12 Months |
| Phase 3: Rate of >= CR | The rate of >= CR is defined as the percentage of participants who achieve a sCR or CR determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new anti-myeloma therapy. | Up to Approximately 12 Months |
| Phase 3: Rate of >= VGPR or Better | The rate of >= VGPR is defined as the percentage of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new anti-myeloma therapy. | Up to Approximately 12 Months |
| Phase 3: ORR | ORR is defined as percentage of participants with a response of PR or better per IMWG criteria. | Up to Approximately 52 Weeks |
| Phase 3: Time to Response (TTR) | TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by investigator. | Up to Approximately 12 Months |
| Phase 3: Duration of Response (DOR) | DOR is defined as the number of days from the day the response criteria are met to the date that disease progression. | Up to Approximately 16 Years |
| Phase 3: Time-to-Progression (TTP) | Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse. | Up to Approximately 16 Years |
| Phase 3: Event Free Survival (EFS) | EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death. | Up to Approximately 16 Years |
| Phase 3: Progression-Free Survival on Subsequent Therapy (PFS2) | PFS2 is defined as the duration from the date of randomization to the date of confirmed disease progression or death on the next line of therapy. | Up to Approximately 16 Years |
| Phase 3: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability | Incidence, severity, seriousness, and causality of TEAEs | Up to Approximately 16 Years |
| Phase 3: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Score | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). | Up to Approximately 16 Years |
| Phase 3: Change from Baseline in EORTC QLQ-C30 Global Health Status/QoL Score | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). | Up to Approximately 16 Years |
| Phase 3: Change from Baseline and Time to Deterioration in the Remaining Scales and Items of EORTC QLQ-C30 | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Subjects rate items on a 4- point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). | Up to Approximately 16 Years |
| Phase 3: Symptomatic AEs as Assessed by the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present). | Up to Approximately 16 Years |
| Phase 3: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) GP5 | The FACT-G GP5 Item is a part of the FACT-G which is a 27-item questionnaire that measures four domains of health-related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being. The FACT-G GP5 item ("I am bothered by side effects of treatment") is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on patients. This item is rated on a 5-point Likert scale from "not at all" to "very much.". | Up to Approximately 16 Years |
| Phase 3: Change from Baseline in Patient Global Impression of Severity (PGIS) Scores | The PGIS scale asks the patient to assess their overall QoL, as well as difficulty of doing physical activities due to MM over the past 7 days. Each item employs a 5-point Likert scale from "not at all" to "very much." | Up to Approximately 16 Years |
| Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores | The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. | Up to Approximately 16 Years |
| Cedars-Sinai Medical Center /ID# 278238 |
| Recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
| Colorado Blood Cancer Institute /ID# 279080 | Recruiting | Denver | Colorado | 80218 | United States |
| Winship Cancer Institute of Emory University /ID# 277667 | Recruiting | Atlanta | Georgia | 30322 | United States |
| Fort Wayne Medical Oncology And Hematology /ID# 278141 | Recruiting | Fort Wayne | Indiana | 46804 | United States |
| Minnesota Oncology - Minneapolis Clinic /ID# 278720 | Recruiting | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic Hospital Rochester /ID# 277886 | Recruiting | Rochester | Minnesota | 55905 | United States |
| Icahn School of Medicine at Mount Sinai /ID# 277844 | Recruiting | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946 | Recruiting | New York | New York | 10065 | United States |
| Weill Cornell Medicine Myeloma Center /ID# 278216 | Recruiting | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill /ID# 277708 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Willamette Valley Cancer Institute and Research Center /ID# 278721 | Recruiting | Eugene | Oregon | 97401 | United States |
| SCRI Oncology Partners /ID# 278353 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - The Woodlands /ID# 278726 | Recruiting | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Northeast Texas /ID# 278725 | Recruiting | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 278716 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Blue Ridge Cancer Care - Roanoke /ID# 278722 | Recruiting | Roanoke | Virginia | 24014 | United States |
| Centre Hospitalier Annecy Genevois /ID# 278406 | Recruiting | Epagny Metz Tessy | Auvergne-Rhône-Alpes | 74370 | France |
| Centre Hospitalier De Dunkerque-Hospital Alexandra Lepeve /ID# 278399 | Recruiting | Dunkirk | Hauts-de-France | 59385 | France |
| Chu De Lille - Hopital Claude Huriez /ID# 278413 | Recruiting | Lille | Hauts-de-France | 59037 | France |
| CHU de Montpellier - Hopital Saint Eloi /ID# 278415 | Recruiting | Montpellier | Herault | 34295 | France |
| CHRU Tours - Hopital Bretonneau /ID# 279274 | Recruiting | Tours | Indre-et-Loire | 37044 | France |
| CH Bretagne Atlantique /ID# 278422 | Recruiting | Vannes | Morbihan | 56000 | France |
| Centre Hospitalier Universitaire de Bordeaux /ID# 278419 | Recruiting | Pessac | New Aquitaine | 33604 | France |
| Centre Hospitalier Universitaire de Poitiers /ID# 278398 | Recruiting | Poitiers | New Aquitaine | 86021 | France |
| IUCT Oncopole /ID# 278403 | Recruiting | Toulouse | Occitanie | 31059 | France |
| Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402 | Recruiting | Nantes | Pays de la Loire Region | 44000 | France |
| Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421 | Recruiting | St-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
| HCL - Hopital Lyon Sud /ID# 282145 | Recruiting | Pierre-Bénite | Rhone | 69495 | France |
| Hopital Saint-Louis /ID# 278429 | Recruiting | Paris | 75010 | France |
| Hopital Saint Antoine /ID# 278428 | Recruiting | Paris | 75012 | France |
| Hopital Universitaire Necker Enfants Malades /ID# 278426 | Recruiting | Paris | Île-de-France Region | 75015 | France |
| Nagoya City University Hospital /ID# 278188 | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
| Matsuyama Red Cross Hospital /ID# 278660 | Recruiting | Matsuyama | Ehime | 790-8524 | Japan |
| Kurume University Hospital /ID# 278209 | Recruiting | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Tokai University Hospital /ID# 278157 | Recruiting | Isehara | Kanagawa | 259-1193 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 278156 | Recruiting | Kyoto | Kyoto | 602-8566 | Japan |
| Complejo Hospitalario Universitario de Santiago /ID# 278531 | Recruiting | Santiago de Compostela | A Coruna | 15706 | Spain |
| Institut Catala d'Oncologia (ICO) - Badalona /ID# 278522 | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Marques de Valdecilla /ID# 278535 | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527 | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Clinica Universidad de Navarra - Pamplona /ID# 278583 | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinic de Barcelona /ID# 278532 | Recruiting | Barcelona | 08036 | Spain |
| Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534 | Recruiting | León | 24071 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 278551 | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 278533 | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre /ID# 278520 | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario de Salamanca /ID# 278530 | Recruiting | Salamanca | 37007 | Spain |
| Hospital Universitari i Politecnic La Fe /ID# 278525 | Recruiting | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| C556306 | daratumumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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