History of Changes for Study: NCT05286229

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

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Study Record Versions

Version	Submitted Date	Changes
1	March 17, 2022	None (earliest Version on record)
2	April 14, 2022	Recruitment Status, Study Status, Contacts/Locations, Eligibility and Oversight
3	April 21, 2022	Contacts/Locations and Study Status
4	May 19, 2022	Study Status, Contacts/Locations and Eligibility
5	June 9, 2022	Study Status and Contacts/Locations
6	July 11, 2022	Contacts/Locations, Study Status, Eligibility and Outcome Measures
7	July 21, 2022	Contacts/Locations and Study Status
8	October 24, 2022	Study Status
9	January 25, 2023	Study Status and Contacts/Locations
10	February 10, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design
11	February 14, 2023	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	M22-984
Brief Title:	A Study to Assess Adverse Events and Change in Disease State of Intravenously (IV) Infused ABBV-383 of Adult Participants With Relapsed or Refractory Multiple Myeloma in Japan
Official Title:	A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABBV-383 Monotherapy in Japanese Subjects With Relapsed or Refractory Multiple Myeloma (4L+ RRMM Monotherapy Study)
Secondary IDs:

Study Status


Record Verification:	March 2022
Overall Status:	Not yet recruiting
Study Start:	April 18, 2022
Primary Completion:	December 25, 2024 [Anticipated]
Study Completion:	December 25, 2024 [Anticipated]

First Submitted:	March 17, 2022
First Submitted that Met QC Criteria:	March 17, 2022
First Posted:	March 18, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	March 17, 2022
Last Update Posted:	March 18, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	AbbVie
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

Multiple myeloma (MM) is an incurable disease characterized by the growth of monoclonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease state of ABBV-383 in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state 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. Two doses of ABBV-383 will be explored. Each treatment arm receives a different dose of ABBV-383 to determine a tolerable dose. Approximately 12 adult participants with R/R MM will be enrolled in the study in approximately 6 sites in Japan.

Participants will receive intravenous (IV) ABBV-383 at two increasing doses in 21-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, and and monitoring of side effects.

Detailed Description:

Conditions


Conditions:	Relapsed/Refractory Multiple Myeloma
Keywords:	Relapsed/Refractory Multiple Myeloma ABBV-383 Cancer

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:	12 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Cohort 1 (ABBV-383 Dose A) Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 dose A in 21-day cycles.	Drug: ABBV-383 Intravenous (IV) Infusion
Experimental: Cohort 2 (ABBV-383 Dose B) Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 dose B in 21-day cycles.	Drug: ABBV-383 Intravenous (IV) Infusion

Outcome Measures


Primary Outcome Measures:
1.	Number of Dose-Limiting Toxicities (DLT) [ Time Frame: Up to Approximately 12 Months ] DLT events are defined as adverse events or abnormal laboratory values assessed as "reasonable possibility" of relationship to the administration of ABBV-383, which cannot be attributed by the investigator to a clearly identifiable cause such as disease progression or concurrent illness.
2.	Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 24 Months ] 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.
Secondary Outcome Measures:
1.	Objective Response Rate (ORR) [ Time Frame: Up to Approximately 24 Months ] ORR is defined as the percentage of participants who achieve confirmed partial response (PR) or better determined by International Myeloma Working Group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy.
2.	Clinical Benefit Rate (CBR) [ Time Frame: Up to Approximately 24 Months ] CBR is defined as complete response (CR) + PR + minimal response (MR) for 24 weeks.
3.	Duration of Clinical Benefit Response (DCBR) [ Time Frame: Up to Approximately 24 Months ] DCBR is defined as the duration of complete response (CR) + PR + minimal response (MR) for 24 weeks.
4.	Progression Free Survival (PFS) [ Time Frame: Up to Approximately 24 Months ] PFS is defined as the duration from the date of first dose to the date of disease progression (PD) determined by IMWG criteria, or death, whichever occurs first.
5.	Time to Response (TTR) [ Time Frame: Up to Approximately 24 Months ] TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by investigator.
6.	Duration of Response (DOR) [ Time Frame: Up to Approximately 24 Months ] DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented.
7.	Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Up to Approximately 24 Months ] MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity.

Eligibility


Minimum Age:	20 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Must have adequate bone marrow function as defined in the protocol. Must meet laboratory parameters as outlined in the protocol. Must have a 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. Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma. Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy. Must have received at least 3 prior lines of therapy (including exposure to a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 mAb) and are refractory to a PI and IMiD. Must have measurable disease within 28 days of enrollment, defined as at least 1 of the following: Serum M-protein >= 0.5 g/dL (>= 5 g/L). Urine M-protein >= 200 mg/24 hours. Serum free light chain (FLC) >= 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein. Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 12 weeks prior to screening and without intervening treatment. Exclusion Criteria: - Has received B-cell maturation antigen (BCMA)-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.

Contacts/Locations


Central Contact Person:	ABBVIE CALL CENTER Telephone: 844-663-3742 Email: abbvieclinicaltrials@abbvie.com
Study Officials:	ABBVIE INC. Study Director AbbVie
Locations:	Japan, Chiba
	National Cancer Center Hospital East /ID# 240943 Kashiwa-shi, Chiba, Japan, 277-8577
	Japan, Hokkaido
	Hokkaido University Hospital /ID# 242672 Sapporo-shi, Hokkaido, Japan, 060-8648
	Japan, Ishikawa
	Kanazawa University Hospital /ID# 240948 Kanazawa-shi, Ishikawa, Japan, 920-8641
	Japan, Okayama
	Okayama Medical Center /ID# 240949 Okayama-shi, Okayama, Japan, 701-1192
	Japan, Osaka
	Osaka University Hospital /ID# 242032 Suita-shi, Osaka, Japan, 565-0871
	Japan, Yamagata
	Yamagata University Hospital /ID# 240945 Yamagata-shi, Yamagata, Japan, 990-9585

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: