Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma

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
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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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