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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512146-41-00 | Other Identifier | EU CT |
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Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.
Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.
In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.
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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.
B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: ABBV-383 Dose Escalation | Experimental | In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration. |
|
| Phase 2: ABBV-383 Dose Expansion Dose A | Experimental | In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration. |
|
| Phase 2: ABBV-383 Dose Expansion Dose B | Experimental | In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etentamig | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) | 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 56 Days |
| 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 129 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Response (PR) Response Rate (RR) | PR is defined >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a >= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a >= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >= 30%, >= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center /ID# 266921 | Recruiting | Beverly Hills | California | 90211 | 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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| Iberdomide | Drug | Oral Capsule |
|
| Up to 3 Years |
| Very Good Partial Response (VGPR) RR | VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein < 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as >= 90% decrease in the difference between involved and uninvolved FLC levels. | Up to 3 Years |
| Complete Response (CR) RR | CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required. | Up to 3 Years |
| Stringent Complete Response (sCR) RR | sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio <= 4:1 or >= 1:2 for kappa and lambda participants, respectively, after counting >= 100 plasma cells). | Up to 3 Years |
| Overall Response Rate (ORR) | ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better. | Up to 3 Years |
| 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 or death. | Up to 3 Years |
| Duration of Response (DOR) | DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first. | Up to 3 Years |
| 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 3 Years |
| Minimal Residual Disease (MRD) negativity | The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status. | Up to 3 Years |
| Colorado Blood Cancer Institute /ID# 273751 |
| Recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| Washington University /ID# 266972 | Recruiting | St Louis | Missouri | 63110 | United States |
| Rutgers Cancer Institute of New Jersey /ID# 266833 | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282 | Recruiting | New York | New York | 10065 | United States |
| University Of North Carolina Health Care - Hillsborough Campus /ID# 278230 | Recruiting | Hillsborough | North Carolina | 27278 | United States |
| Swedish Medical Center - Seattle /ID# 268052 | Recruiting | Seattle | Washington | 98104 | United States |
| Blacktown Hospital /ID# 265983 | Recruiting | Blacktown | New South Wales | 2148 | Australia |
| Wollongong Hospital /ID# 265625 | Recruiting | Wollongong | New South Wales | 2500 | Australia |
| The Alfred Hospital /ID# 265981 | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Austin Hospital /ID# 265984 | Recruiting | Melbourne | Victoria | 3084 | Australia |
| Sir Charles Gairdner Hospital /ID# 265985 | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| University Health Network_Princess Margaret Cancer Centre /ID# 275636 | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital /ID# 267574 | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| Chu de Nice-Hopital Larchet Ii /Id# 266845 | Recruiting | Nice | Alpes-Maritimes | 06202 | France |
| Hôpital La Timone /ID# 267053 | Recruiting | Marseille | Bouches-du-Rhone | 13885 | France |
| Chu De Lille - Hopital Claude Huriez /ID# 270193 | Recruiting | Lille | Hauts-de-France | 59037 | France |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694 | Recruiting | Tours | Indre-et-Loire | 37000 | France |
| IUCT Oncopole /ID# 266391 | Recruiting | Toulouse | Occitanie | 31059 | France |
|
| National Cancer Center Hospital East /ID# 268343 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Kumamoto University Hospital /ID# 270530 | Recruiting | Kumamoto | Kumamoto | 860-8556 | Japan |
| Dokkyo Medical University Hospital /ID# 271648 | Recruiting | Mibu | Tochigi | 321-0293 | Japan |
| Nippon Medical School Hospital /ID# 270254 | Recruiting | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 268342 | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
| Amsterdam UMC, Location VUmc /ID# 267670 | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 267660 | Recruiting | Utrecht | 3584 CX | Netherlands |
| Oslo Universitetssykehus Ulleval /ID# 275433 | Recruiting | Oslo | 0450 | Norway |
| 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 |
|---|---|
| C000624220 | iberdomide |
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