What side effects are associated with this type of intervention?

Daratumumab, a monoclonal antibody targeting CD38, is associated with higher rates of neutropenia, lymphocytopenia, and infections, including pneumonia and viral reactivations such as herpes zoster and CMV. Lenalidomide, an immunomodulatory drug, commonly causes neutropenia and infections, with a higher risk of severe infections during induction and maintenance therapy. Combining these drugs can increase the risk of these side effects.

What prior FDA approvals exist?

Daratumumab, a monoclonal antibody targeting CD38, has been approved by the FDA for the treatment of multiple myeloma in various settings, including in combination with other drugs like bortezomib, melphalan, and dexamethasone. Lenalidomide, an immunomodulatory drug, is also FDA-approved for multiple myeloma and is often used in combination with dexamethasone. Other related FDA-approved treatments include pomalidomide, another immunomodulatory drug, and other monoclonal antibodies like elotuzumab and isatuximab, which target different antigens on myeloma cells.

What other types of research exist?

Promising novel alternatives to Daratumumab and Lenalidomide for Multiple Myeloma patients include: <ol> <li>Isatuximab (another anti-CD38 monoclonal antibody) combined with carfilzomib and dexamethasone, which has shown efficacy in relapsed multiple myeloma.</li> <li></li> </ol> Belantamab mafodotin, an antibody-drug conjugate targeting BCMA, which has demonstrated activity in relapsed or refractory multiple myeloma. 3. Teclistamab, a bispecific antibody targeting BCMA and CD3, which has shown promise in relapsed or refractory multiple myeloma. 4. Selinexor, a selective inhibitor of nuclear export, used in combination with bortezomib and dexamethasone, which has been effective in previously treated multiple myeloma.

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Monoclonal Antibodies

Daratumumab + Lenalidomide for Multiple Myeloma

Phase 2

Waitlist Available

Led By Frank Passero, MD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

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

Must have

A performance status ≤ 3

Female subjects of child bearing potential must be surgically sterile, be post-menopausal

Must not have

Diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma

Diagnosis of Waldenström's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two medications, daratumumab and lenalidomide, for treating multiple myeloma without using steroids. It focuses on patients who cannot have a transplant. Daratumumab helps the immune system destroy cancer cells, and lenalidomide boosts the immune system and stops cancer growth.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who haven't had previous treatments and can't have a transplant. They should be able to take oral meds, not be pregnant or breastfeeding, and must not have other severe health issues or recent major surgeries.

What is being tested?

The study tests the effectiveness of daratumumab and lenalidomide without steroids in treating multiple myeloma. It aims to see if patients can avoid steroid-related side effects while still controlling their cancer effectively.

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related reactions from daratumumab, blood clots due to lenalidomide, as well as potential risks like infections, fatigue, nausea, diarrhea, and rash.

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 but cannot do any physical work.

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I am a woman who cannot become pregnant because I am either surgically sterile or post-menopausal.

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I can swallow and keep down pills.

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I have been recently diagnosed and am not eligible for high-dose chemotherapy.

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I have not been treated for multiple myeloma before.

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I have been diagnosed with multiple myeloma.

Exclusion Criteria

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

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I have been diagnosed with a specific blood disorder but it's not active cancer.

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I have been diagnosed with Waldenström's disease.

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I was diagnosed with cancer less than 2 years ago.

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I do not have any severe or uncontrolled medical conditions.

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I am not pregnant or breastfeeding.

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I have not had major surgery in the last 2 weeks.

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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.

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I cannot take medications to prevent blood clots.

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I have not had radiation therapy in the last 14 days.

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I am currently fighting a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Daratumumab Related Infusion Reactions

Secondary study objectives

Determination of Response Rates

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

44%

Thrombocytopenia

38%

Peripheral sensory neuropathy

38%

Peripheral Sensory Neuropathy

32%

Anaemia

24%

Fatigue

22%

Diarrhoea

17%

Upper respiratory tract infection

17%

Upper Respiratory Tract Infection

16%

Constipation

15%

Insomnia

15%

Asthenia

13%

Cough

11%

Nausea

11%

Neuralgia

11%

Pyrexia

11%

Dizziness

10%

Back pain

10%

Back Pain

10%

Pneumonia

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Arthralgia

Headache

Paraesthesia

Bronchitis

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Dyspepsia

Hypocalcaemia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Hypophosphataemia

Rash

Abdominal Pain Upper

Conjunctivitis

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Muscle spasms

Aspartate aminotransferase increased

Urinary tract infection

Myalgia

Herpes zoster

Musculoskeletal chest pain

Herpes Zoster

Pulmonary Embolism

Weight Decreased

Pulmonary embolism

Myocardial infarction

Dehydration

Myocardial Infarction

Lower Respiratory Tract Infection

Abdominal Pain

Orthostatic Hypotension

General Physical Health Deterioration

General physical health deterioration

Hyponatraemia

Condition aggravated

Orthostatic hypotension

Lower respiratory tract infection

Syncope

Productive cough

Nasal congestion

Respiratory failure

Weight decreased

Chills

Gastroenteritis

Sepsis

Respiratory Failure

Condition Aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Bortezomib + Dexamethasone (Vd)

Daratumumab + Bortezomib and Dexamethasone (DVd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm: Cycle 5+ Partial Response or BetterExperimental Treatment2 Interventions

Group II: Experimental Arm: Cycle 1-4 All subjectsActive Control3 Interventions

Subjects will be treated with the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Group III: Experimental Arm: Cycle 5+ Less than Partial ResponseActive Control3 Interventions

Subjects will be treated the following: * Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks * Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle * Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Daratumumab

2014

Completed Phase 3

~2000

0 / 16Eligibility 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 on myeloma cells, inducing cell death through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. Lenalidomide is an immunomodulatory drug that enhances immune response by inhibiting angiogenesis, promoting T-cell and natural killer cell activity, and inducing apoptosis. These mechanisms are vital for Multiple Myeloma patients as they provide targeted approaches to eliminate cancer cells, potentially improving treatment efficacy and allowing for personalized therapy strategies.