Back to resultsA 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
Primary Purpose
Relapsed/Refractory Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ABBV-383
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring Relapsed/Refractory Multiple Myeloma, ABBV-383, Cancer
Eligibility 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).
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.
Sites / Locations
- National Cancer Center Hospital East /ID# 240943
- Hokkaido University Hospital /ID# 242672
- Kanazawa University Hospital /ID# 240948
- Okayama Medical Center /ID# 240949
- Osaka University Hospital /ID# 242032
- Yamagata University Hospital /ID# 240945
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1 (ABBV-383 Dose A)
Cohort 2 (ABBV-383 Dose B)
Arm Description
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.
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 dose B in 21-day cycles.
Outcomes
Primary Outcome Measures
Number of Dose-Limiting Toxicities (DLT)
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.
Number of Participants with Adverse Events (AE)
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
Objective Response Rate (ORR)
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.
Progression Free Survival (PFS)
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.
Time to Response (TTR)
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.
Duration of Response (DOR)
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.
Minimal Residual Disease (MRD) Negativity Rate
MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05286229
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
March 24, 2024 (Anticipated)
Study Completion Date
March 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
Relapsed/Refractory Multiple Myeloma, ABBV-383, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (ABBV-383 Dose A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2 (ABBV-383 Dose B)
Arm Type
Experimental
Arm Description
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 dose B in 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
ABBV-383
Intervention Description
Intravenous (IV) Infusion
Primary Outcome Measure Information:
Title
Number of Dose-Limiting Toxicities (DLT)
Description
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.
Time Frame
Up to Approximately 12 Months
Title
Number of Participants with Adverse Events (AE)
Description
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.
Time Frame
Up to Approximately 24 Months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to Approximately 24 Months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to Approximately 24 Months
Title
Time to Response (TTR)
Description
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.
Time Frame
Up to Approximately 24 Months
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to Approximately 24 Months
Title
Minimal Residual Disease (MRD) Negativity Rate
Description
MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity.
Time Frame
Up to Approximately 24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Center Hospital East /ID# 240943
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 242672
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 240948
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Okayama Medical Center /ID# 240949
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Osaka University Hospital /ID# 242032
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Yamagata University Hospital /ID# 240945
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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