Clinical trial 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
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed/Refractory Multiple Myeloma
Keywords: Relapsed/Refractory Multiple Myeloma
ABBV-383
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Dose-Limiting Toxicities (DLT)
timeFrame: Up to Approximately 12 Months
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to Approximately 24 Months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to Approximately 24 Months
measure: Progression Free Survival (PFS)
timeFrame: Up to Approximately 24 Months
measure: Time to Response (TTR)
timeFrame: Up to Approximately 24 Months
measure: Duration of Response (DOR)
timeFrame: Up to Approximately 24 Months
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Up to Approximately 24 Months
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 240943
state: Chiba
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 242672
state: Hokkaido
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 240948
state: Ishikawa
city: Okayama-shi
country: Japan
facility: Okayama Medical Center /ID# 240949
state: Okayama
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 242032
state: Osaka
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 240945
state: Yamagata
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: