What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those similar to the ABBV-383 trial combinations, include pomalidomide, lenalidomide, daratumumab, and nirogacestat. Known side effects of these treatments can include hematologic toxicities such as neutropenia, thrombocytopenia, and anemia. Non-hematologic side effects often include gastrointestinal issues (nausea, vomiting, diarrhea), fatigue, infections, and peripheral neuropathy. Specific to daratumumab, infusion-related reactions and respiratory infections are common. Pomalidomide and lenalidomide can also cause rash, muscle spasms, and increased risk of thromboembolic events. Nirogacestat, being less commonly used, may have a different side effect profile that is still being studied.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of multiple myeloma, particularly for relapsed or refractory cases. Lenalidomide and pomalidomide, both immunomodulatory drugs, have been approved for use in combination with dexamethasone. Daratumumab, an anti-CD38 monoclonal antibody, has also received approval for use in combination with other agents like lenalidomide and dexamethasone. Bortezomib, a proteasome inhibitor, is another key drug that has been approved for multiple myeloma treatment, often used in combination with dexamethasone and other agents. These drugs are similar to those being studied in the ABBV-383 trial, which aims to assess the safety and efficacy of ABBV-383 in combination with these established treatments.

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 in multiple myeloma and are in various stages of clinical development.

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Monoclonal Antibodies

ABBV-383 Combo for Multiple Myeloma

Q: What is the mechanism of action of this treatment?

Common treatments for Multiple Myeloma include immunomodulatory drugs like pomalidomide and lenalidomide, monoclonal antibodies like daratumumab, and investigational drugs like nirogacestat. Pomalidomide and lenalidomide work by enhancing the immune system's ability to attack myeloma cells and inhibiting their growth. Daratumumab targets CD38 on myeloma cells, leading to their destruction by the immune system. Nirogacestat is a gamma-secretase inhibitor that disrupts signaling pathways crucial for myeloma cell survival. These mechanisms are vital for patients as they offer targeted approaches to control and reduce the disease, especially in cases where the myeloma has relapsed or is refractory to initial treatments.

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

Must have confirmed diagnosis of 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) criteria

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

Must not have

Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose

Known central nervous system involvement Multiple Myeloma (MM)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ABBV-383, combined with other medications to treat adults with difficult-to-treat multiple myeloma. The study aims to find the safest and most effective dose while monitoring side effects and disease response. Participants will receive ongoing medical check-ups and tests throughout the trial.

Who is the study for?

Adults with relapsed/refractory multiple myeloma who've had previous treatments can join this trial. They must have a certain level of physical ability (ECOG <=2), measurable disease, and no prior BCMA-targeted therapy. Exclusions include recent major surgery, active infections or uncontrolled conditions like diabetes or hypertension, recent stem cell transplants, unresolved side effects from past cancer therapies, central nervous system involvement in MM, and certain other medical conditions.

What is being tested?

The study is testing ABBV-383 combined with anti-cancer regimens (Pd/Rd/Dd/Niro) for safety and effect on disease activity in multiple myeloma patients. Participants are grouped to receive different combinations intravenously over 28-day cycles. The trial includes phases to find the best dose of ABBV-383 and confirm it through more participants at various global sites.

What are the potential side effects?

Potential side effects may include reactions related to IV infusion such as discomfort or pain at the injection site, allergic reactions; blood disorders; fatigue; organ inflammation; increased risk of infection due to immune system suppression by chemotherapy drugs used alongside ABBV-383.

Eligibility Criteria

Inclusion Criteria

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

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My multiple myeloma has returned or didn't respond to treatment, as confirmed by tests.

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

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I have previously received treatment for multiple myeloma in specific trial arms.

Exclusion Criteria

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

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I have severe nerve pain or damage in my hands or feet.

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My multiple myeloma has spread to my brain or spinal cord.

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I have no ongoing major side effects from previous cancer treatments.

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My multiple myeloma does not produce detectable levels of M protein.

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I have been diagnosed with light chain amyloidosis.

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I have a high number of plasma cells in my blood, indicating active plasma cell leukemia.

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I have not had any serious infections needing treatment in the last 14 days.

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I have been diagnosed with POEMS syndrome.

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I had a stem cell transplant from my own cells within the last 12 weeks or from a donor within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

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

Number of Participants with Adverse Events (AEs)

Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383

Secondary study objectives

Duration of Response (DOR)

Overall Response Rate (ORR)

Percentage of Participants with Minimal Residual Disease Negativity (MRD)

+2 more

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 D (ABBV-383 with Nirogacestat)Experimental Treatment2 Interventions

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.

Group II: Arm C (ABBV-383 with Daratumumab and Dexamethasone)Experimental Treatment3 Interventions

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.

Group III: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)Experimental Treatment3 Interventions

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.

Group IV: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)Experimental Treatment3 Interventions

Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Pomalidomide

2011

Completed Phase 2

~1060

Daratumumab

2014

Completed Phase 3

~2380

Lenalidomide

2005

Completed Phase 3

~2240

0 / 12Eligibility 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 include immunomodulatory drugs like pomalidomide and lenalidomide, monoclonal antibodies like daratumumab, and investigational drugs like nirogacestat. Pomalidomide and lenalidomide work by enhancing the immune system's ability to attack myeloma cells and inhibiting their growth. Daratumumab targets CD38 on myeloma cells, leading to their destruction by the immune system. Nirogacestat is a gamma-secretase inhibitor that disrupts signaling pathways crucial for myeloma cell survival. These mechanisms are vital for patients as they offer targeted approaches to control and reduce the disease, especially in cases where the myeloma has relapsed or is refractory to initial treatments.

How best to use new therapies in multiple myeloma.