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

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial will test the effectiveness of daratumumab and lenalidomide in treating multiple myeloma without the use of steroids.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daratumumab Related Infusion Reactions

Secondary outcome measures

Determination of Response Rates

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

60%

Thrombocytopenia

50%

Peripheral sensory neuropathy

47%

Peripheral Sensory Neuropathy

36%

Upper respiratory tract infection

36%

Diarrhoea

29%

Cough

28%

Anaemia

23%

Fatigue

23%

Upper Respiratory Tract Infection

23%

Constipation

21%

Back pain

20%

Oedema peripheral

20%

Arthralgia

19%

Neutropenia

19%

Dyspnoea

18%

Insomnia

17%

Pyrexia

16%

Oedema Peripheral

15%

Nausea

14%

Lymphopenia

14%

Pain in extremity

14%

Nasopharyngitis

14%

Bronchitis

14%

Neuralgia

13%

Back Pain

13%

Dizziness

12%

Decreased appetite

12%

Vomiting

12%

Headache

12%

Hypertension

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Hypokalaemia

10%

Musculoskeletal chest pain

10%

Muscle spasms

Leukopenia

Urinary tract infection

Bone pain

Decreased Appetite

Hyperglycaemia

Pain in Extremity

Bronchospasm

Muscle Spasms

Abdominal pain upper

Alanine aminotransferase increased

Weight decreased

Hypophosphataemia

Herpes zoster

Influenza

Hypocalcaemia

Alanine Aminotransferase Increased

Rash

Musculoskeletal Chest Pain

Abdominal pain

Aspartate aminotransferase increased

Myalgia

Nasal congestion

Chills

Bone Pain

Hypotension

Abdominal Pain Upper

Weight Decreased

Throat irritation

Productive cough

Herpes Zoster

Oedema

Paraesthesia

Epistaxis

Dyspepsia

Acute kidney injury

Atrial fibrillation

Sepsis

Atrial Fibrillation

Acute myocardial infarction

Hip fracture

Femur fracture

Pulmonary sepsis

Pathological fracture

Squamous cell carcinoma of skin

Lower Respiratory Tract Infection

Rib fracture

Pneumonia cytomegaloviral

Pulmonary Sepsis

Hypercalcaemia

Pneumonia Cytomegaloviral

Cardiac failure congestive

Acute coronary syndrome

Cerebrovascular accident

Ischaemic stroke

Humerus fracture

Pleural effusion

Respiratory failure

Gastroenteritis

Bronchitis chronic

Febrile neutropenia

Angina unstable

Lower respiratory tract infection

Ischaemic Stroke

Respiratory Failure

Pathological Fracture

Febrile Neutropenia

Cardiac Failure Congestive

Bronchopneumonia

Femur Fracture

Humerus Fracture

Acute Kidney Injury

Pleural Effusion

100%

80%

60%

40%

20%

Study treatment Arm

Daratumumab + Bortezomib and Dexamethasone (DVd)

Bortezomib + Dexamethasone (Vd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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

Daratumumab

2014

Completed Phase 3

~1990

Lenalidomide

2005

Completed Phase 2

~1070

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

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.