What side effects are associated with this type of intervention?

The most common treatments for Multiple Myeloma, particularly those similar to the D-ClaPd regimen (Daratumumab, Clarithromycin, Pomalidomide, and Dexamethasone), have several known side effects. Daratumumab is associated with higher rates of neutropenia, lymphocytopenia, and infections, including pneumonia and viral reactivations. Pomalidomide commonly causes neutropenia, anemia, and infections, including pneumonia. Dexamethasone can lead to hyperglycemia, increased infection risk, and gastrointestinal issues. Clarithromycin can cause gastrointestinal disturbances and potential drug interactions. Combining these agents may increase the risk of severe infections and hematologic toxicities.

What prior FDA approvals exist?

Daratumumab, an anti-CD38 monoclonal antibody, has been FDA-approved for use in combination with various agents for the treatment of Multiple Myeloma, including with Pomalidomide and Dexamethasone. Pomalidomide, an immunomodulatory drug, is also approved in combination with Dexamethasone for relapsed or refractory Multiple Myeloma. Other similar treatments include Isatuximab, another anti-CD38 monoclonal antibody, approved in combination with Pomalidomide and Dexamethasone. These combinations aim to enhance efficacy by leveraging the synergistic effects of immunomodulation, anti-inflammatory properties, and direct anti-myeloma activity.

What other types of research exist?

Promising alternatives to the D-ClaPd regimen for Multiple Myeloma patients include: 1) Carfilzomib, Pomalidomide, and Dexamethasone (KPd), which has shown efficacy in patients refractory to lenalidomide and daratumumab. 2) Isatuximab, Pomalidomide, and Dexamethasone (Isa-Pd), another anti-CD38 monoclonal antibody combination that has demonstrated effectiveness in relapsed/refractory Multiple Myeloma. 3) Selinexor, Bortezomib, and Dexamethasone (SVd), which is a novel combination for patients with triple-class refractory Multiple Myeloma. These regimens offer alternative mechanisms of action and have been evaluated in clinical trials for their efficacy and safety.

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Daratumumab Combo for Multiple Myeloma

Phase 2

Recruiting

Led By Cara Rosenbaum, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Relapsed and/or refractory myeloma meeting specific criteria

Must not have

Female patients who are lactating or have a positive serum pregnancy test during the screening period

Recent myocardial infarction or severe obstructive airway disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combination of four drugs for patients with multiple myeloma who did not respond to previous treatments. The drugs work together to boost the immune system, fight infections, reduce inflammation, and directly target cancer cells.

Who is the study for?

This trial is for adults with Multiple Myeloma that has come back or hasn't responded to treatment. They must have measurable disease, be able to take aspirin, and not be pregnant or breastfeeding. Participants should be in decent physical shape (ECOG 0-2) and expected to live more than 3 months. They can't join if they've had certain treatments recently, other cancers, severe illnesses that could affect the study, allergies to the drugs used in this trial, or some heart/lung conditions.

What is being tested?

The study tests a combination therapy called D-ClaPd on patients who've previously been treated with Daratumumab. It's a phase II trial where participants receive Daratumumab subcutaneously along with Clarithromycin/Pomalidomide/Dexamethasone until their disease progresses or side effects become too much.

What are the potential side effects?

Possible side effects include reactions at the injection site for Daratumumab SC; nausea, taste changes from Clarithromycin; blood clots and fatigue from Pomalidomide; and weight gain, high blood sugar from Dexamethasone. There may also be an increased risk of infections.

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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My myeloma has returned or is not responding to treatment.

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My condition is confirmed as Multiple Myeloma through tissue analysis.

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I can take aspirin every day.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I have not had a recent heart attack or severe lung blockage.

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I have specific heart or lung conditions.

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I have been treated with specific non-daratumumab anti-CD38 drugs or pomalidomide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 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

Very Good Partial Response Rate or better within 8 cycles of induction therapy

Secondary study objectives

Complete Response Rate or Better

Duration of Response

Overall Response Rate

+8 more

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: daratumumab/clarithromycin/pomalidomide/dexamethasoneExperimental Treatment4 Interventions

Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab SC

2014

Completed Phase 3

~710

Clarithromycin

2017

Completed Phase 4

~3950

Pomalidomide

2011

Completed Phase 2

~1060

Dexamethasone

2007

Completed Phase 4

~2650

0 / 8Eligibility 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

Daratumumab is a monoclonal antibody that targets CD38, a protein highly expressed on myeloma cells, leading to cell death through immune-mediated mechanisms. Clarithromycin, an antibiotic, has immunomodulatory effects that can enhance the efficacy of other treatments. Pomalidomide is an immunomodulatory drug that promotes anti-tumor immunity and inhibits myeloma cell growth. Dexamethasone is a corticosteroid that reduces inflammation and suppresses the immune system, helping to control myeloma symptoms and enhance the effects of other drugs. These mechanisms are crucial for Multiple Myeloma patients as they target the cancer cells directly, modulate the immune response, and manage symptoms, thereby improving treatment outcomes and quality of life.

CD38-targeting antibodies in multiple myeloma: mechanisms of action and clinical experience.Daratumumab and its potential in the treatment of multiple myeloma: overview of the preclinical and clinical development.