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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06223516
Other study ID # M23-001
Secondary ID 2023-507901-32-0
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 21, 2024
Est. completion date February 21, 2027

Study information

Verified date June 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world In Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date February 21, 2027
Est. primary completion date February 21, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance of <= 2. - Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug. - Must be naïve to treatment with ABBV-383. Exclusion Criteria: - Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Subcutaneous (SC) ABBV-383
SC Injection
Intravenous (IV) ABBV-383
IV Infusion

Locations

Country Name City State
Israel Tel Aviv Sourasky Medical Center /ID# 261525 Tel Aviv Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity. Up to 2 cycles (56 days)
Primary Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events ICANS events will be graded using ASTCT, with a higher grade indicating higher severity. Up to 2 cycles (56 days)
Primary Maximum Observed Concentration (Cmax) of ABBV-383 Cmax of ABBV-383. Up to 32 weeks
Primary Time to Cmax (Tmax) of ABBV-383 Tmax of ABBV-383. Up to 32 weeks
Primary Trough Concentration (Ctrough) of ABBV-383 Ctrough of ABBV-383. Up to 32 weeks
Primary Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383 AUC of ABBV-383. Up to 24 weeks
Secondary Overall Response Rate (ORR) The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by international myeloma working group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy. Up to 24 months
Secondary Percentage of Participants Achieving Stringent Complete Response (sCR), sCR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, normal free light chain (FLC) ratio, and Absence of clonal cells in bone marrow by immunohistochemistry. Up to 24 months
Secondary Percentage of Participants Achieving Complete Response (CR) CR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio. Up to 24 months
Secondary Percentage of Participants Achieving Very Good Partial Response (VGPR) VGPR is defined as participants achieving serum and urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein plus urine, and for participants in whom the only measurable disease is by serum FLC levels, >= 90% decrease in the difference between involved and uninvolved FLC levels. Up to 24 months
Secondary Percentage of Participants Achieving Partial Response (PR) PR is defined as participants achieving >= 50% reduction of serum M-protein, reduction in 24-hour urinary M-protein by >= 90% as noted in the protocol, >= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. Up to 24 months
Secondary Duration of Response (DoR) DoR will be defined as the time from the date of first response [partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR)] to the earliest occurrence of progressive disease, or death, whatever occurs first. Up to 24 months
Secondary Progression Free Survival (PFS) PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) per international myeloma working group (IMWG) criteria, or death, whichever occurs first. Up to 24 months
Secondary Time to Response (TTR) 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. Up to 24 months
Secondary Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs) Incidence and concentration of ADAs. Up to 27 months
Secondary Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs) Incidence and concentration of NAbs. Up to 27 months
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