What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, especially those involving Daratumumab (an anti-CD38 monoclonal antibody), often include combinations with Lenalidomide, Bortezomib, and Dexamethasone. Known side effects of these treatments include neutropenia, upper respiratory tract infections, fatigue, diarrhea, hypertension, and infusion-related reactions. More severe side effects can include grade 3 or 4 infections, pneumonia, and cardiac failure. Patients may also experience anemia, thrombocytopenia, and gastrointestinal issues such as vomiting and diarrhea. Neuropathy is a dose-limiting side effect, particularly with Bortezomib.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies like daratumumab and isatuximab, both of which target CD38. Daratumumab is often used in combination with lenalidomide and dexamethasone (DRd) or with bortezomib and dexamethasone (DVd). Isatuximab is approved for use with pomalidomide and dexamethasone (IsaPd). Other related drugs include elotuzumab, which is used with lenalidomide and dexamethasone (ERd), and carfilzomib, which can be combined with lenalidomide and dexamethasone (KRd). These combinations have shown efficacy in improving progression-free survival in patients with Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to Daratumumab for Multiple Myeloma patients include Isatuximab (another anti-CD38 monoclonal antibody), Belantamab mafodotin (an antibody-drug conjugate targeting BCMA), Teclistamab (a bispecific antibody targeting BCMA), and Venetoclax (a BCL-2 inhibitor, particularly effective in patients with t(11;14) translocation). These therapies have shown efficacy in clinical trials and are considered potential options for treatment in 2024.

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Immunomodulatory agents

Daratumumab + Lenalidomide for Multiple Myeloma (AURIGA Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies' NGS based MRD assay)

Must have archived bone marrow samples collected before induction treatment or before transplant, or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay

Must not have

Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification

Must not have progressed on multiple myeloma (MM) therapy at any time prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4.1 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding daratumumab to lenalidomide is more effective than using lenalidomide alone for patients with newly diagnosed multiple myeloma. These patients still have detectable cancer cells after initial treatments. Daratumumab helps the immune system find and kill cancer cells, while lenalidomide boosts the immune system and stops cancer growth.

Who is the study for?

This trial is for individuals with newly diagnosed multiple myeloma who have had at least 4 cycles of induction therapy, a stem cell transplant within the last year, and are still showing minimal residual disease. They should be in relatively good health (ECOG score 0-2) and not have been treated with Daratumumab or similar drugs before.

What is being tested?

The study tests if adding Daratumumab to Lenalidomide maintenance treatment helps patients achieve negative status for minimal residual disease compared to using Lenalidomide alone after a stem cell transplant in those who haven't previously received CD38-targeting treatments.

What are the potential side effects?

Daratumumab can cause infusion reactions, fatigue, nausea, back pain, fever and cough. Lenalidomide may lead to blood clots, diarrhea, itching/rash and tiredness. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have remaining cancer cells detected by a specific blood test.

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I have bone marrow samples or MRD test results from before my treatment.

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I am able to care for myself and perform daily activities.

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My myeloma treatment has been very effective according to IMWG 2016 criteria.

Exclusion Criteria

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

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I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.

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My multiple myeloma has not worsened during any previous treatments.

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I have COPD with less than half the normal lung function.

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My multiple myeloma is affecting my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4.1 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4.1 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.1 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

Percentage of Participants with Minimal Residual Disease (MRD) Negative Status as determined by NGS

Secondary study objectives

Change in HRQoL as Measured by EORTC QLQ-Multiple Myeloma Module (MY20)

Change in HRQoL as Measured by European Quality of Life Five Dimensions Questionnaire-5-level (EQ-5D-5L)

Change in Health-Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30

+7 more

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%

Pneumonia

10%

Back pain

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

Hypocalcaemia

Dyspepsia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Rash

Abdominal Pain Upper

Conjunctivitis

Hypophosphataemia

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Aspartate aminotransferase increased

Muscle spasms

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

Condition aggravated

General physical health deterioration

Hyponatraemia

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Daratumumab + LenalidomideExperimental Treatment2 Interventions

Participants will receive 1800 milligram (mg) daratumumab by subcutaneous (SC) injection in combination with lenalidomide (orally) as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.

Group II: LenalidomideActive Control1 Intervention

Participants will receive lenalidomide (orally) alone as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2000

Lenalidomide

2005

Completed Phase 3

~2240

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

Multiple Myeloma treatments often target specific proteins or pathways involved in the growth and survival of myeloma cells. Daratumumab, an anti-CD38 monoclonal antibody, binds to the CD38 protein on the surface of myeloma cells, leading to cell death through immune-mediated mechanisms. Lenalidomide, an immunomodulatory drug, enhances the immune system's ability to attack myeloma cells and inhibits their growth. Bortezomib, a proteasome inhibitor, disrupts protein degradation in myeloma cells, causing cell death. These treatments are crucial as they target the disease at a molecular level, improving patient outcomes by reducing tumor burden and prolonging survival.