History of Changes for Study: NCT05650632

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Latest version (submitted February 2, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	December 6, 2022	None (earliest Version on record)
2	March 22, 2023	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	April 19, 2023	Contacts/Locations and Study Status
4	May 11, 2023	Study Status
5	May 15, 2023	Contacts/Locations and Study Status
6	May 16, 2023	Study Status
7	May 18, 2023	Contacts/Locations and Study Status
8	May 24, 2023	Contacts/Locations and Study Status
9	June 28, 2023	Study Status and Study Identification
10	July 6, 2023	Study Status
11	July 10, 2023	Contacts/Locations and Study Status
12	July 19, 2023	Contacts/Locations and Study Status
13	August 2, 2023	Study Status and Contacts/Locations
14	August 22, 2023	Contacts/Locations and Study Status
15	August 28, 2023	Contacts/Locations and Study Status
16	August 30, 2023	Contacts/Locations and Study Status
17	September 4, 2023	Study Status and Contacts/Locations
18	September 7, 2023	Contacts/Locations and Study Status
19	September 11, 2023	Contacts/Locations and Study Status
20	November 9, 2023	Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Eligibility, Study Design, Study Description and Study Identification
21	December 1, 2023	Study Status
22	December 20, 2023	Contacts/Locations and Study Status
23	January 29, 2024	Contacts/Locations and Study Status
24	February 2, 2024	Study Status and Contacts/Locations

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Study NCT05650632
Submitted Date: December 6, 2022 (v1)

Study Identification


Unique Protocol ID:	M24-108
Brief Title:	A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Official Title:	A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary IDs:	EU CT 2022-502399-21-00 [EU CT]

Study Status


Record Verification:	December 2022
Overall Status:	Not yet recruiting
Study Start:	April 1, 2023
Primary Completion:	May 30, 2026 [Anticipated]
Study Completion:	May 30, 2026 [Anticipated]

First Submitted:	December 6, 2022
First Submitted that Met QC Criteria:	December 6, 2022
First Posted:	December 14, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	December 6, 2022
Last Update Posted:	December 14, 2022 [Actual]

Study Description

Brief Summary:

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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 adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383. Around 80 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 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.

Detailed Description:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Sequential Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	80 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: ABBV-383 Dose Escalation Participants will receive different doses of ABBV-383 in 28 day cycles.	Drug: ABBV-383 Intravenous Infusion
Experimental: ABBV-383 Dose Expansion Participants will receive ABBV-383 in 28 day cycles.	Drug: ABBV-383 Intravenous Infusion

Outcome Measures


Primary Outcome Measures:
1.	Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to Day 28 ] CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
Secondary Outcome Measures:
1.	Number of Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to 3 Years ] CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Must have measurable disease as outlined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance of <= 2. 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) 2016 criteria. Must be naïve to treatment with ABBV-383. Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody. Exclusion Criteria: - Received B-cell maturation antigen (BCMA)-targeted therapy.

Contacts/Locations


Central Contact Person:	ABBVIE CALL CENTER Telephone: 844-663-3742 Email: abbvieclinicaltrials@abbvie.com
Study Officials:	TeneoOne Inc Study Director TeneoOne Inc.
Locations:	United States, Arizona
	Mayo Clinic Arizona /ID# 251405 Phoenix, Arizona, United States, 85054
	United States, Louisiana
	Tulane University /ID# 251204 New Orleans, Louisiana, United States, 70112-2005
	United States, Minnesota
	Mayo Clinic - Rochester /ID# 251164 Rochester, Minnesota, United States, 55905-0001
	United States, New York
	Mt Sinai /ID# 251166 New York, New York, United States, 10029-6542
	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167 New York, New York, United States, 10065-6007
	United States, North Carolina
	Wake Forest Univ HS /ID# 251165 Winston-Salem, North Carolina, United States, 27157 Contact:Contact: Site Coordinator (336) 716-2011
	France, Auvergne-Rhone-Alpes
	HCL - Hopital Lyon Sud /ID# 251223 Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
	Israel
	Rabin Medical Center /ID# 251330 Petakh Tikva, Israel, 4941492
	Israel, Tel-Aviv
	The Chaim Sheba Medical Center /ID# 251329 Ramat Gan, Tel-Aviv, Israel, 5265601
	Tel Aviv Sourasky Medical Center /ID# 251573 Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
	Israel, Yerushalayim
	Hadassah Medical Center-Hebrew University /ID# 252079 Jerusalem, Yerushalayim, Israel, 91120
	United Kingdom
	The Christie Hospital /ID# 251774 Manchester, United Kingdom, M20 4BX
	United Kingdom, Nottinghamshire
	Nottingham University Hospitals NHS Trust /ID# 251358 Nottingham, Nottinghamshire, United Kingdom, NG5 1PB

References


Citations:
Links:	URL: https://www.abbvieclinicaltrials.com/study/?id=M24-108 Description: Related Info
Available IPD/Information:

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