What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving monoclonal antibodies and targeted therapies like BCMA-targeting agents, often have several side effects. Teclistamab, an anti-BCMA antibody, has been associated with high rates of neutropenia (64.2%), infections (44.8%), and pneumonia (12.7%). Other treatments, such as carfilzomib and bortezomib, can cause peripheral neuropathy, gastrointestinal issues, and hematologic toxicities like thrombocytopenia and neutropenia. Additionally, therapies like daratumumab can lead to infusion reactions, respiratory infections, and fatigue. These side effects highlight the need for careful monitoring and supportive care during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma that target BCMA, similar to the investigational drug HDP-101. Notably, belantamab mafodotin (Blenrep) is an ADC targeting BCMA, approved for patients with relapsed or refractory Multiple Myeloma. Additionally, other BCMA-targeting therapies include idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), both of which are CAR T-cell therapies. These treatments represent significant advancements in targeting BCMA, a protein commonly expressed on myeloma cells, and offer new options for patients with this challenging disease.

What other types of research exist?

Promising novel alternatives to HDP-101 for Multiple Myeloma patients include: 1) CAR T-cell therapies targeting BCMA, such as idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti). 2) Bispecific antibodies targeting BCMA and CD3, such as teclistamab. 3) Other antibody-drug conjugates like belantamab mafodotin. These therapies have shown significant efficacy in clinical trials and are expected to be important treatment options in 2024.

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HDP-101 for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by Heidelberg Pharma AG

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2

Male or female aged ≥18 years

Must not have

Patients with positive test results for hepatitis C virus (HCV) infection

Known central nervous system involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing HDP-101, a new treatment for patients with plasma cell disorders like multiple myeloma who haven't responded to other treatments. HDP-101 works by targeting a protein on cancer cells to help the immune system destroy them.

Who is the study for?

This trial is for adults over 18 with relapsed or refractory multiple myeloma who have tried other treatments including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapy. They should not be eligible for a stem cell transplant or must have already had one. Participants need to be in relatively stable health (ECOG PS 0-2) and cannot join if they've recently received certain cancer therapies, have active infections like hepatitis B/C or HIV, heart failure, or any other active cancers.

What is being tested?

The study is testing HDP-101's safety and effectiveness in patients with multiple myeloma. It will look at how the body processes the drug (pharmacokinetics), its tolerability at different doses, and its potential as a treatment option compared to current standards.

What are the potential side effects?

While specific side effects of HDP-101 are not listed here, common side effects from similar treatments include nausea, fatigue, infusion reactions (like fever or chills), blood count changes that can increase infection risk, liver issues, kidney problems and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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I have had a stem cell transplant or am not eligible for one.

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I have been diagnosed with active multiple myeloma.

Exclusion Criteria

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

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I have tested positive for hepatitis C.

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My cancer has spread to my brain or spinal cord.

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I have a history of heart failure.

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I have an active liver or biliary disease.

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I have been diagnosed with plasma cell leukemia.

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I had or plan to have a stem cell transplant using my own or donor cells within 12 weeks.

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I have had symptoms of graft versus host disease after a stem cell transplant in the last year.

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I do not have any other active cancers.

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I am currently taking medication for an active infection.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Assess the safety and tolerability of HDP-101

To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: HDP-101Experimental Treatment1 Intervention

Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.

0 / 14Eligibility 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

The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), monoclonal antibodies (e.g., daratumumab), and Antibody-Drug Conjugates (ADCs) like HDP-101 targeting BCMA. Proteasome inhibitors disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs enhance the immune response against myeloma cells. Monoclonal antibodies target specific antigens on myeloma cells, marking them for destruction by the immune system. ADCs combine an antibody specific to a myeloma cell antigen (e.g., BCMA) with a cytotoxic drug, delivering targeted therapy to kill cancer cells while sparing healthy tissue. These mechanisms are crucial as they offer targeted, effective treatments that can improve survival and quality of life for Multiple Myeloma patients.

Advances in multiple myeloma therapy during two past decades.