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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05286229
Recruitment Status : Active, not recruiting
First Posted : March 18, 2022
Last Update Posted : February 15, 2023
Information provided by (Responsible Party):

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05286229

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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
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie Identifier: NCT05286229    
Other Study ID Numbers: M22-984
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases