A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma Clinical Trial

Official title:

A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259839
• Other study ID #: M22-947
• Secondary ID: 2021-005587-22
• Status: Recruiting
• Phase: Phase 1
• Start date: October 20, 2022
• Est. completion date: July 21, 2031

Study information

• Verified date: March 2024
• Source: TeneoOne Inc.
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro 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 ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide. Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 21, 2031
• Est. primary completion date: November 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 outlined in the protocol.
• Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
• Has received prior MM treatment in Arms A, B, C, and D.

Exclusion Criteria:

• Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug 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.
• Known central nervous system involvement Multiple Myeloma (MM).
• Has any of the following conditions:
• Nonsecretory 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 drug 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.
• Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Drug:
• ABBV-383
Intravenous (IV) Infusion
• Dexamethasone
Oral; Tablet or IV Infusion
• Lenalidomide
Oral; Capsule
• Pomalidomide
Oral; Capsule
• Nirogacestat
Oral; Tablet
• Daratumumab
Subcutaneous Injection (SC)

Locations

Country	Name	City	State
Australia	Monash Medical Centre /ID# 244403	Clayton	Victoria
Australia	St Vincent's Hospital Melbourne /ID# 256879	Fitzroy Melbourne	Victoria
Australia	St George Hospital /ID# 243740	Kogarah	New South Wales
Australia	Peter MacCallum Cancer Ctr /ID# 256880	Melbourne	Victoria
Australia	Fiona Stanley Hospital /ID# 244753	Murdoch	Western Australia
Australia	Epworth Healthcare /ID# 243734	Richmond	Victoria
Australia	Calvary Mater Newcastle /ID# 243730	Waratah	New South Wales
Germany	Universitaetsklinikum Essen /ID# 242819	Essen
Germany	Universitaetsklinikum Hamburg-Eppendorf /ID# 243141	Hamburg
Germany	Universitaetsklinikum Regensburg /ID# 242837	Regensburg
Germany	Universitaetsklinikum Tuebingen /ID# 242815	Tubingen	Baden-Wuerttemberg
Germany	Universitaetsklinikum Wuerzburg /ID# 242826	Wuerzburg
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 242581	Bologna
Italy	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 242584	Meldola
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057	Milan
Italy	Ospedale San Raffaele IRCCS /ID# 242583	Milan	Milano
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582	Rome	Lazio
Japan	Kanazawa University Hospital /ID# 246812	Kanazawa-shi	Ishikawa
Japan	National Cancer Center Hospital East /ID# 245889	Kashiwa-shi	Chiba
Japan	Nagoya City University Hospital /ID# 249094	Nagoya shi	Aichi
Japan	Okayama Medical Center /ID# 245882	Okayama-shi	Okayama
Japan	Hokkaido University Hospital /ID# 245966	Sapporo-shi	Hokkaido
Japan	Yamagata University Hospital /ID# 245888	Yamagata-shi	Yamagata
Poland	Uniwersyteckie Centrum Kliniczne /ID# 243249	Gdansk	Pomorskie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 243500	Lublin	Lubelskie
Poland	Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954	Opole	Dolnoslaskie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocawiu /ID# 243246	Wroclaw	Dolnoslaskie
Spain	Hospital Clinic de Barcelona /ID# 242978	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 242976	Barcelona
Spain	Hospital Duran i Reynals /ID# 242979	Hospitalet de Llobregat	Barcelona
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 242975	Madrid
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 242977	Pamplona	Navarra
Spain	Hospital Universitario Virgen del Rocio /ID# 242974	Sevilla
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438	Ann Arbor	Michigan
United States	University of Maryland School of Medicine /ID# 243679	Baltimore	Maryland
United States	Dana-Farber Cancer Institute /ID# 249529	Boston	Massachusetts
United States	Levine Cancer Institute /ID# 242851	Charlotte	North Carolina
United States	University of Texas Southwestern Medical Center /ID# 243273	Dallas	Texas
United States	University of Arkansas for Medical Sciences /ID# 243096	Little Rock	Arkansas
United States	Sylvester Comprehensive Cancer Center /ID# 243673	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital /ID# 242654	Milwaukee	Wisconsin
United States	Memorial Sloan Kettering Cancer Center /ID# 244656	New York	New York
United States	Rutenberg Cancer Center /ID# 244647	New York	New York
United States	The Valley Hospital /ID# 243829	Paramus	New Jersey
United States	Huntsman Cancer Institute /ID# 242872	Salt Lake City	Utah
United States	University of Washington /ID# 243172	Seattle	Washington
United States	Moffitt Cancer Center /ID# 243437	Tampa	Florida
United States	University of Massachusetts - Worcester /ID# 243977	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
TeneoOne Inc.

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Italy,  Japan,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383	DLT events as described in the protocol will be assessed.	Up to approximately 28 Days
Primary	Number of Participants with Adverse Events (AEs)	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.	Up to Approximately 3 Years
Secondary	Overall Response Rate (ORR)	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.	Up to Approximately 3 Years
Secondary	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 Approximately 3 Years
Secondary	Duration of Response (DOR)	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.	Up to Approximately 3 Years
Secondary	Time-to-Progression (TTP)	TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.	Up to Approximately 3 Years
Secondary	Percentage of Participants with Minimal Residual Disease Negativity (MRD)	MRD is defined as the percentage of participants with assessment of the minimal residual disease.	Up to Approximately 3 Years