NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071230131

Registered date:28/03/2024

[M24-209] An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedImmunoglobulin Light Chain (AL) Amyloidosis
Date of first enrollment27/03/2024
Target sample size76
Countries of recruitment
Study typeInterventional
Intervention(s)ABBV-383: Intravenous Infusion (Other Names: TNB-383B)

Outcome(s)

Primary OutcomeNumber of Participants with Dose-Limiting Toxicities (DLT) [Time Frame: Up to 28 Days]
Secondary Outcome1. Percentage of Participants who Achieve Hematologic Complete Response (CR) [Time Frame: Up to 3 Years] - Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the International Amyloidosis Consensus Criteria. 2. Overall Hematologic Response (OHR) [Time Frame: Up to 3 Years] - OHR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR), proportion of participants who achieved a PR or better, per the International Amyloidosis Consensus Criteria. 3. Time to Hematologic CR [Time Frame: Up to 3 Years] - Time to hematologic CR is defined as the time from first dose of study drug until CR, per the International Amyloidosis Consensus Criteria. 4. Duration of Hematologic CR [Time Frame: Up to 3 Years] - Duration of hematologic CR is defined as the time from CR until disease progression, per the International Amyloidosis Consensus Criteria. 5. Organ Response Rate (OrRR) [Time Frame: Up to 3 Years] - Organ response rate is defined as the time from first dose of study drug until to response in the heart kidney and liver, per the International Amyloidosis Consensus Criteria. 6. Time to Organ Response [Time Frame: Up to 3 Years] - Time to organ response is defined as the time from first dose of study drug until organ response, per the International Amyloidosis Consensus Criteria.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis. 2. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. 3. Have at least 1 organ historically impacted by AL amyloidosis. 4. Considered AL amyloidosis risk stage 1, 2, or 3a and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L. 5. Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Exclude criteria1. Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months. 2. Known allergic reaction, significant sensitivity, or intolerance to constituents of the study drugs (and excipients) and/or other products in the same class. 3. Participant has the following conditions i. Other non-AL amyloid disease ii. Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, >= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium > 11 mg/dL) iii. Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or > 2.0 X 109/L circulating plasma cells by standard differential) iv. Waldenstrom's macroglobulinemia v. Acute diffuse infiltrative pneumopathy vi. Major surgery within 28 days prior first dose or planned during study participation vii. History of organ transplant requiring continued use of immunosuppressants viii. Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral) ix. Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study drug treatment.

Related Information

Contact

Public contact
Name Contact for Patients and HCP
Address 3-1-21, Shibaura, Minato-ku, Tokyo, Japan Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K.
Scientific contact
Name Natsuko Satomi
Address 3-1-21, Shibaura, Minato-ku, Tokyo, Japan Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K.