Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515770-27-00 | Other Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, 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 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 1: Etentamig Dose Escalation | Experimental | Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration. |
|
| Substudy 1: Etentamig Dose Expansion Dose Level 1 | Experimental | Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration. |
|
| Substudy 1: Etentamig Dose Expansion Dose Level 2 | Experimental | Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration. |
|
| Substudy 1: Comparator | Experimental | Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration. |
|
| Substudy 2: Etentamig Dose Escalation | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etentamig | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE)s | An adverse event 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 130 Months |
| Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM) | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. | Up to Approximately 8 weeks |
| Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM) | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. | Up to Approximately 8 Weeks |
| Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM) | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. | Up to Approximately 8 Weeks |
| Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Substudy 1, 2, 3, 4: Complete Response Rate | Complete response rate is defined as complete response (CR), stringent complete response (sCR) as assessed by the international myeloma working group (IMWG) 2016 criteria for MM. | Up to Approximately 1 Year |
| Substudy 1, 2, 3, 4: Overall Response Rate (ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute /ID# 273129 | Recruiting | Denver | Colorado | 80218 | 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/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will receive escalating etentamig, as part of the approximately 130 month study duration. |
|
| Substudy 2: Etentamig Dose Expansion Dose Level 1 | Experimental | Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration. |
|
| Substudy 2: Etentamig Dose Expansion Dose Level 2 | Experimental | Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration. |
|
| Substudy 2: Comparator | Experimental | Participants will receive lenalidomide (R), as part of the approximately 130 month study duration. |
|
| Substudy 3: Etentamig Dose Escalation | Experimental | Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration. |
|
| Substudy 3: Etentamig Dose Expansion Dose Level 1 | Experimental | Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration. |
|
| Substudy 3: Etentamig Dose Expansion Dose Level 2 | Experimental | Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration. |
|
| Substudy 3: Comparator | Experimental | Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration. |
|
| Substudy 4: Etentamig Dose Escalation | Experimental | Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration. |
|
| Substudy 4: Etentamig Dose Expansion Dose Level 1 | Experimental | Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration. |
|
| Substudy 4: Etentamig Dose Expansion Dose Level 2 | Experimental | Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration. |
|
| Lenalidomide | Drug | Oral Capsule |
|
| Dexamethasone | Drug | IV Injection |
|
| Daratumumab | Drug | Subcutaneous Injection |
|
| Dexamethasone | Drug | Oral Tablet |
|
| Carfilzomib | Drug | IV Infusion |
|
| Up to Approximately 8 Weeks |
The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by IMWG criteria, prior to the initiation of subsequent myeloma therapy. |
| Up to Approximately 1 Year |
| Substudy 1, 2, 3, 4: Progression Free Survival (PFS) | PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IMWG) or death. | Up to Approximately 130 Months |
| Substudy 1, 2, 3, 4: Duration of Response (DOR) | DOR is defined as the time from the date of first response to the earliest occurrence of progressive disease, or death, whatever occurs first. | Up to Approximately 130 Months |
| Substudy 1, 2, 3, 4: Time-to-Progression (TTP) | TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression. | Up to Approximately 130 Months |
| Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity | The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status. | Up to Approximately 52 Weeks |
| Moffitt Cancer Center /ID# 272628 |
| Recruiting |
| Tampa |
| Florida |
| 33612 |
| United States |
| Winship Cancer Institute of Emory University /ID# 274830 | Recruiting | Atlanta | Georgia | 30322 | United States |
| Weill Cornell Medical College /ID# 272517 | Recruiting | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill /ID# 274667 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Atrium Health Levine Cancer Institute /ID# 276193 | Recruiting | Charlotte | North Carolina | 28204-2990 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 274847 | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Oncology Hematology Care - Kenwood /ID# 272918 | Recruiting | Cincinnati | Ohio | 45236 | United States |
| Coffs Harbour Health Campus /ID# 272010 | Recruiting | Coffs Harbour | New South Wales | 2450 | Australia |
| Port Macquarie Base Hospital /ID# 275925 | Recruiting | Port Macquarie | New South Wales | 2444 | Australia |
| Westmead Hospital /ID# 271880 | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Icon Cancer Care - South Brisbane /ID# 271836 | Recruiting | South Brisbane | Queensland | 4101 | Australia |
| Royal Adelaide Hospital /ID# 272629 | Recruiting | Adelaide | South Australia | 5000 | Australia |
| St Vincent's Hospital - Melbourne /ID# 276451 | Recruiting | Fitzroy | Victoria | 3065 | Australia |
| Peter MacCallum Cancer Centre /ID# 272024 | Recruiting | Melbourne | Victoria | 3000 | Australia |
| The Perth Blood Institute - West Perth /ID# 272469 | Recruiting | West Perth | Western Australia | 6005 | Australia |
| Soroka Medical Center /ID# 271367 | Recruiting | Beersheba | Southern District | 8410101 | Israel |
| The Chaim Sheba Medical Center /ID# 271366 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Campus- Haifa /ID# 271364 | Recruiting | Haifa | 3525408 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 271362 | Recruiting | Jerusalem | 91120 | Israel |
| Rabin Medical Center. /ID# 271365 | Recruiting | Petah Tikva | 4941492 | Israel |
| Nagoya City University Hospital /ID# 273529 | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 275713 | Recruiting | Kyoto | Kyoto | 602-8566 | Japan |
| The University of Osaka Hospital /ID# 275791 | Recruiting | Suita-shi | Osaka | 565-0871 | Japan |
|
| Hammersmith Hospital /ID# 274615 | Recruiting | London | England | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| C524865 | carfilzomib |
| 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 |
Not provided
Not provided