A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- Registration Number
- NCT05259839
- Lead Sponsor
- TeneoOne Inc.
- Brief Summary
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 safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity 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. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide.
Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-day cycles.
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 side effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
- Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
- Must have measurable disease as determined by central lab as outlined in the protocol.
- Must be naïve to treatment with Etentamig.
- Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
- Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
- Arm E: Participant has received 1-3 prior lines of MM treatment.
-
Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
-
Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
-
Has any of the following conditions:
- Nonsecretory Multiple Myeloma (MM).
- Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
- Waldenstrom's macroglobulinemia.
- Light chain amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
- Major surgery within 4 weeks prior to first dose or planned study participation.
- Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
- Uncontrolled diabetes or hypertension within 14 days prior to first dose.
- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone) Dexamethasone Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone. Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone) Pomalidomide Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone. Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone) Lenalidomide Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone. Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone) Etentamig Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone. Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone) Dexamethasone Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone. Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone) Dexamethasone Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone. Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone) Daratumumab Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone. Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone) Dexamethasone Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy. Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone) Pomalidomide Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy. Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone) Etentamig Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy. Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone) Etentamig Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone. Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone) Etentamig Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig Up to approximately 28 Days DLT events as described in the protocol will be assessed.
Number of Participants with Adverse Events (AEs) Up to Approximately 3 Years 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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to Approximately 3 Years ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
Progression-Free Survival (PFS) Up to Approximately 3 Years PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
Duration of Response (DOR) Up to Approximately 3 Years DOR will be 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.
Time-to-Progression (TTP) Up to Approximately 3 Years TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS) Up to Approximately 3 Years MRD negative status (threshold as assessed by NGS Adaptive Clonoseq) with \>= CR (per International Myeloma Working Group \[IMWG\] response criteria) prior to the initiation of new myeloma therapy.
Trial Locations
- Locations (49)
Hospital Universitario Virgen del Rocio /ID# 242974
🇪🇸Sevilla, Spain
St George Hospital /ID# 243740
🇦🇺Kogarah, New South Wales, Australia
University of Arkansas for Medical Sciences /ID# 243096
🇺🇸Little Rock, Arkansas, United States
Sylvester Comprehensive Cancer Center /ID# 243673
🇺🇸Miami, Florida, United States
Moffitt Cancer Center /ID# 243437
🇺🇸Tampa, Florida, United States
University of Maryland, Baltimore /ID# 243679
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute /ID# 249529
🇺🇸Boston, Massachusetts, United States
University of Massachusetts - Worcester /ID# 243977
🇺🇸Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
🇺🇸Ann Arbor, Michigan, United States
The Valley Hospital /ID# 243829
🇺🇸Paramus, New Jersey, United States
Rutenberg Cancer Center /ID# 244647
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center /ID# 244656
🇺🇸New York, New York, United States
Levine Cancer Institute /ID# 242851
🇺🇸Charlotte, North Carolina, United States
University of Texas Southwestern Medical Center /ID# 243273
🇺🇸Dallas, Texas, United States
Huntsman Cancer Institute /ID# 242872
🇺🇸Salt Lake City, Utah, United States
University of Washington /ID# 243172
🇺🇸Seattle, Washington, United States
Froedtert Memorial Lutheran Hospital /ID# 242654
🇺🇸Milwaukee, Wisconsin, United States
Calvary Mater Newcastle /ID# 243730
🇦🇺Waratah, New South Wales, Australia
Monash Health - Monash Medical Centre /ID# 244403
🇦🇺Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 256879
🇦🇺Fitzroy Melbourne, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 256880
🇦🇺Melbourne, Victoria, Australia
Epworth Healthcare /ID# 243734
🇦🇺Richmond, Victoria, Australia
Fiona Stanley Hospital /ID# 244753
🇦🇺Murdoch, Western Australia, Australia
Universitaetsklinikum Tuebingen /ID# 242815
🇩🇪Tubingen, Baden-Wuerttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 242826
🇩🇪Wuerzburg, Bayern, Germany
Universitaetsklinikum Essen /ID# 242819
🇩🇪Essen, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 243141
🇩🇪Hamburg, Germany
Universitaetsklinikum Regensburg /ID# 242837
🇩🇪Regensburg, Germany
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 242581
🇮🇹Bologna, Emilia-Romagna, Italy
IRCCS Ospedale San Raffaele /ID# 242583
🇮🇹Milan, Milano, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584
🇮🇹Meldola, Reggio Emilia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582
🇮🇹Rome, Roma, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 244057
🇮🇹Milano, Italy
Nagoya City University Hospital /ID# 249094
🇯🇵Nagoya shi, Aichi, Japan
National Cancer Center Hospital East /ID# 245889
🇯🇵Kashiwa-shi, Chiba, Japan
Hokkaido University Hospital /ID# 245966
🇯🇵Sapporo-shi, Hokkaido, Japan
Kanazawa University Hospital /ID# 246812
🇯🇵Kanazawa-shi, Ishikawa, Japan
Okayama Medical Center /ID# 245882
🇯🇵Okayama-shi, Okayama, Japan
Yamagata University Hospital /ID# 245888
🇯🇵Yamagata-shi, Yamagata, Japan
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954
🇵🇱Opole, Dolnoslaskie, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu /ID# 243246
🇵🇱Wroclaw, Dolnoslaskie, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
🇵🇱Lublin, Lubelskie, Poland
Uniwersyteckie Centrum Kliniczne /ID# 243249
🇵🇱Gdansk, Pomorskie, Poland
Hospital Duran i Reynals /ID# 242979
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 242977
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Vall d'Hebron /ID# 242976
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona /ID# 242978
🇪🇸Barcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 242975
🇪🇸Madrid, Spain