Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Overview

About this study

The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance of < = 2.

- Confirmed diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented
evidence of progression during or after the participant's last treatment based on the
Investigator's determination of the international myeloma working group (IMWG) (2016)
response criteria.

- Must have measurable disease with at least 1 of the following assessed within 28 days
of enrollment:

- Serum M-protein > = 0.5 g/dL (> = 5 g/L).

- Urine M-protein > = 200 mg/24 hours.

- In participants without measurable serum or urine M protein, serum free light
chain (FLC) > = 100 mg/L (10 mg/dL) (involved light chain).

- Must have received at least 2 or more lines of therapy, including a proteasome
inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody
(mAb).

- Must be naïve to treatment with B-cell maturation antigen (BCMA)-targeted therapy.

- Must be eligible to receive the Investigator's choice standard available therapy (SAT)
based on approved prescribing information, previous MM treatment history, and
institutional guidelines.

Exclusion Criteria:

- Clinically significant (per Investigator's judgment) drug or alcohol abuse within the
last 6 months.

- Clinically significant conditions such as but not limited to the following: renal,
neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary,
or hepatic disease within the last 6 months that would adversely affect the
participant's participation in the study.

- Central nervous system involvement of MM.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/29/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Vivek Roy, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Saurabh Chhabra, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20580867

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