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

Tracking Information

• First Submitted Date: March 17, 2022
• First Posted Date: March 18, 2022
• Last Update Posted Date: February 15, 2023
• Actual Study Start Date: March 24, 2022
• Estimated Primary Completion Date: March 24, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 17, 2022)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 11, 2022)

• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: March 17, 2022)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)

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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Relapsed/Refractory Multiple Myeloma

Intervention

Drug: ABBV-383

Intravenous (IV) Infusion

Study Arms

• 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.
  Intervention: Drug: ABBV-383
• 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.
  Intervention: Drug: ABBV-383

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 10, 2023): 8
• Original Estimated Enrollment (submitted: March 17, 2022): 12
• Estimated Study Completion Date: March 24, 2024
• Estimated Primary Completion Date: March 24, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT05286229
• Other Study ID Numbers: M22-984
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: February 2023