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

• ClinicalTrials.gov Identifier: NCT05286229
• Recruitment Status: Active, not recruiting
• First Posted: March 18, 2022
• Last Update Posted: February 15, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

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.

Condition or disease	Intervention/treatment	Phase
Relapsed/Refractory Multiple Myeloma	Drug: ABBV-383	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: March 24, 2022
• Estimated Primary Completion Date: March 24, 2024
• Estimated Study Completion Date: March 24, 2024

Arms and Interventions

Arm	Intervention/treatment
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. 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.
3. 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.
4. 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.
5. 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 Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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).

• 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 and Locations

Locations

Japan

National Cancer Center Hospital East /ID# 240943

Kashiwa-shi, Chiba, Japan, 277-8577

Hokkaido University Hospital /ID# 242672

Sapporo-shi, Hokkaido, Japan, 060-8648

Kanazawa University Hospital /ID# 240948

Kanazawa-shi, Ishikawa, Japan, 920-8641

Okayama Medical Center /ID# 240949

Okayama-shi, Okayama, Japan, 701-1192

Osaka University Hospital /ID# 242032

Suita-shi, Osaka, Japan, 565-0871

Yamagata University Hospital /ID# 240945

Yamagata-shi, Yamagata, Japan, 990-9585

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

More Information

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT05286229
• Other Study ID Numbers: M22-984
• First Posted: March 18, 2022
• Last Update Posted: February 15, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by AbbVie:

Relapsed/Refractory Multiple Myeloma; ABBV-383; Cancer

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases