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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

Summary

This trial is testing whether adding daratumumab to lenalidomide can help people with newly diagnosed multiple myeloma who are positive for MRD (as determined by next generation sequencing).

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Minimal Residual Disease (MRD) Negative Status as determined by NGS
Secondary outcome measures
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
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%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Bone pain
9%
Leukopenia
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Hypocalcaemia
7%
Herpes zoster
7%
Influenza
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Abdominal pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
5%
Throat irritation
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Pathological fracture
1%
Femur fracture
1%
Pleural effusion
1%
Lower Respiratory Tract Infection
1%
Angina unstable
1%
Pulmonary sepsis
1%
Hypercalcaemia
1%
Acute myocardial infarction
1%
Hip fracture
1%
Pulmonary Sepsis
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Ischaemic stroke
1%
Rib fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Cerebrovascular accident
1%
Febrile neutropenia
1%
Lower respiratory tract infection
1%
Humerus fracture
1%
Squamous cell carcinoma of skin
1%
Pneumonia cytomegaloviral
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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
~1340

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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,093 Total Patients Enrolled
72 Trials studying Multiple Myeloma
19,395 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,747 Total Patients Enrolled
50 Trials studying Multiple Myeloma
14,354 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide (Immunomodulatory agents) Clinical Trial Eligibility Overview. Trial Name: NCT03901963 — Phase 3
Multiple Myeloma Research Study Groups: Lenalidomide, Daratumumab + Lenalidomide
Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT03901963 — Phase 3
Lenalidomide (Immunomodulatory agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03901963 — Phase 3
~32 spots leftby Jul 2025
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