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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 newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT on the date of randomization
Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.1 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

AURIGA Trial 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.

AURIGA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with multiple myeloma, had 4+ treatment cycles, a stem cell transplant within a year of starting treatment, and it's been less than 6 months since my transplant.
Select...
My myeloma treatment has been very effective according to IMWG 2016 criteria.
Select...
I have bone marrow samples or MRD test results from before my treatment.
Select...
I have remaining cancer cells detected by a specific blood test.
Select...
I am able to care for myself and perform daily activities.

AURIGA Trial 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 2022 Phase 3 trial • 466 Patients • NCT03158688
39%
Thrombocytopenia
37%
Hypertension
37%
Anaemia
36%
Diarrhoea
34%
Upper respiratory tract infection
26%
Fatigue
22%
Dyspnoea
21%
Insomnia
20%
Nausea
20%
Back pain
19%
Pyrexia
18%
Bronchitis
18%
Cough
17%
Vomiting
17%
Pneumonia
16%
Neutropenia
15%
Headache
13%
Muscle spasms
12%
Oedema peripheral
11%
Neuropathy peripheral
11%
Respiratory tract infection
11%
Arthralgia
11%
Asthenia
11%
Nasopharyngitis
9%
Decreased appetite
9%
Hyperglycaemia
9%
Cataract
9%
Lymphopenia
8%
Peripheral sensory neuropathy
8%
Influenza
8%
Pain in extremity
8%
Dizziness
7%
Muscular weakness
7%
Leukopenia
7%
Productive cough
7%
Infusion related reaction
7%
Urinary tract infection
7%
Constipation
7%
Hypokalaemia
7%
Rash
6%
Lower respiratory tract infection
6%
Musculoskeletal chest pain
6%
Hypogammaglobulinaemia
6%
Pharyngitis
6%
Fall
6%
Hypocalcaemia
6%
Myalgia
6%
Pruritus
6%
Chills
5%
COVID-19 pneumonia
5%
COVID-19
5%
Sinusitis
5%
Contusion
5%
Oropharyngeal pain
5%
Conjunctivitis
5%
Oedema
4%
Tachycardia
4%
Abdominal pain
4%
Sepsis
3%
Epistaxis
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Atrial fibrillation
2%
Septic shock
2%
Pulmonary embolism
2%
Pulmonary oedema
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Cellulitis
1%
Pulmonary arterial hypertension
1%
Pulmonary hypertension
1%
Respiratory failure
1%
Infection
1%
Acute coronary syndrome
1%
Myocardial ischaemia
1%
Sudden death
1%
Pneumonia respiratory syncytial viral
1%
Overdose
1%
Blood creatinine increased
1%
Osteonecrosis of jaw
1%
Pathological fracture
1%
Plasmacytoma
1%
Syncope
1%
Febrile neutropenia
1%
Thrombotic thrombocytopenic purpura
1%
Cardiac failure acute
1%
Cardiac failure
1%
Bacteraemia
1%
Upper gastrointestinal haemorrhage
1%
Hepatic function abnormal
1%
Lung infection
1%
Device related infection
1%
Pneumonia cytomegaloviral
1%
Respiratory syncytial virus infection
1%
Hyperkalaemia
1%
Tumour lysis syndrome
1%
Viral infection
1%
Squamous cell carcinoma
1%
Posterior reversible encephalopathy syndrome
1%
Interstitial lung disease
1%
Pleural effusion
1%
Pneumonitis
1%
Cardiac arrest
1%
Myocardial infarction
1%
Acute myocardial infarction
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
KdD - Carfilzomib, Dexamethasone and Daratumumab
Kd - Carfilzomib and Dexamethasone

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.

AURIGA 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
2016
Completed Phase 3
~1750
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
971 Previous Clinical Trials
6,383,384 Total Patients Enrolled
69 Trials studying Multiple Myeloma
19,181 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
743 Previous Clinical Trials
3,959,497 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,186 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide (Immunomodulatory agents) Clinical Trial Eligibility Overview. Trial Name: NCT03901963 — Phase 3
Multiple Myeloma Research Study Groups: Daratumumab + Lenalidomide, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the most common issues that Daratumumab has been shown to help with?

"Daratumumab is often used to treat chronic lymphocytic leukemia. Additionally, this medication can be employed for other purposes such as immunomodulation and amyloidosis in patients that have already tried two different systemic chemotherapy regimens."

Answered by AI

Is this trial taking place at multiple research facilities across the United States?

"This study is being conducted at Franciscan Health in Indianapolis, Indiana; NYU Winthrop in Mineola, New york; Novant Health in Charlotte, North carolina; and 67 other locations."

Answered by AI

What is the background of Daratumumab in regards to other medical research?

"The first Daratumumab clinical trial was completed in 2004 at the Saint Joseph Regional Medical Center-Mishawaka. To date, there have been a total of 375 completed clinical trials worldwide. There are presently 368 live clinical trials underway; many of these out of Indianapolis, Indiana."

Answered by AI

Who would be an eligible candidate to participate in this clinical research?

"This clinical trial is for patients with multiple myeloma who are between 18 and 79 years old. The researchers conducting this study need to enroll around 214 people in total."

Answered by AI

How many individuals are in the experimental group for this clinical research?

"That is correct. The clinical trial, which was initially posted on April 26th, 2019 and updated November 3rd, 2020, is looking for 214 patients at 67 different locations."

Answered by AI

Does this research study consider patients that are 20 or older to be eligible?

"According to the information available, this trial is for patients aged 18-79. Out of the 1221 trials posted, 56 are for patients younger than 18 while the remaining are for those 65 and older."

Answered by AI
~10 spots leftby Jun 2024