What side effects are associated with this type of intervention?

Common treatments for relapsed/refractory multiple myeloma, such as bortezomib, lenalidomide, and dexamethasone, are associated with a range of side effects. Bortezomib can cause peripheral neuropathy, gastrointestinal distress, and cytopenias. Lenalidomide may lead to neutropenia, thrombocytopenia, and increased risk of infections. Dexamethasone is known for causing hyperglycemia, muscle weakness, and increased susceptibility to infections. Combination therapies often result in compounded side effects, including fatigue, diarrhea, and increased risk of severe infections.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of relapsed or refractory multiple myeloma, including bortezomib, lenalidomide, and daratumumab. Bortezomib, a proteasome inhibitor, was approved for patients who have received at least one prior therapy. Lenalidomide, an immunomodulatory drug, is often used in combination with dexamethasone. Daratumumab, a monoclonal antibody, has been approved for use in combination with other agents like bortezomib and dexamethasone. These treatments are similar to the investigational drug ABBV-383, which is being studied for its efficacy in relapsed/refractory multiple myeloma.

What other types of research exist?

Promising novel alternatives to ABBV-383 for relapsed/refractory multiple myeloma patients include Isatuximab (an anti-CD38 monoclonal antibody), Marizomib (a new proteasome inhibitor), Oprozomib (an oral proteasome inhibitor), Filanesib (ARRY-520, a kinesin spindle protein inhibitor), Dinaciclib (a cyclin-dependent kinase inhibitor), and Venetoclax (ABT-199, a selective BCL-2 inhibitor). These agents have shown promising single-agent activity and are in various stages of clinical development.

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Monoclonal Antibodies

ABBV-383 for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by TeneoOne Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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) 2016 criteria.

Must be naïve to treatment with ABBV-383.

Must not have

Arm A: Received BCMA-targeted therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ABBV-383, a new drug for adults with multiple myeloma that has come back or not responded to other treatments. The drug is given through an IV regularly. The study will monitor the drug's effects and any side effects over several years.

Who is the study for?

Adults with Multiple Myeloma that has returned or hasn't improved after treatment can join. They must have had at least 2-3 prior treatments, including specific drugs like proteasome inhibitors and anti-CD38 antibodies. For one part of the study, they shouldn't have had BCMA-targeted therapy before.

What is being tested?

The trial is testing ABBV-383, a new drug for relapsed/refractory Multiple Myeloma. It's given by IV in two parts: first finding the right starting dose then expanding to more patients; another group gets a fixed dose. The study lasts about 3 years with regular hospital visits.

What are the potential side effects?

Specific side effects aren't listed but participants will be closely monitored for any adverse events through medical exams and blood tests during their regular clinic visits throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My multiple myeloma has worsened despite treatment.

Select...

I have never been treated with ABBV-383.

Select...

I've had 3+ treatments including PI, IMiD, and anti-CD38 for my condition.

Select...

I've had 2+ treatments for my condition, including specific targeted therapies.

Select...

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received therapy targeting BCMA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arm A (Part 1 and Part 2) and Arm C: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events

Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])

Secondary study objectives

Arm A and Arm C: Number of Cytokine Release Syndrome (CRS) Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm C: ABBV-383 Step UpExperimental Treatment1 Intervention

Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Group II: Arm B: ABBV-383 BCMA ExposedExperimental Treatment1 Intervention

Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.

Group III: Arm A (Part 2): ABBV-383 Dose ExpansionExperimental Treatment1 Intervention

BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.

Group IV: Arm A (Part 1): ABBV-383 Dose EscalationExperimental Treatment1 Intervention

B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Myeloma, such as the investigational drug ABBV-383, often target specific proteins or pathways critical for the survival and proliferation of myeloma cells. ABBV-383, for instance, is designed to target BCMA (B-cell maturation antigen), a protein highly expressed on MM cells, thereby directing the immune system to attack these cells. Other treatments like proteasome inhibitors (e.g., bortezomib) disrupt protein degradation in cancer cells, leading to cell death, while monoclonal antibodies (e.g., daratumumab) target specific antigens on MM cells to enhance immune-mediated destruction. These mechanisms are vital for MM patients as they offer targeted approaches to control the disease, especially in relapsed or refractory cases where conventional therapies may fail.

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