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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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.1 years
Awards & highlights

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 have remaining cancer cells detected by a specific blood test.
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...
I have bone marrow samples or MRD test results from before my treatment.
Select...
I am able to care for myself and perform daily activities.
Select...
My myeloma treatment has been very effective according to IMWG 2016 criteria.

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 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%
Arthralgia
20%
Oedema peripheral
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%
Bone pain
9%
Leukopenia
9%
Urinary tract infection
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
8%
Weight decreased
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
6%
Aspartate aminotransferase increased
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%
Acute myocardial infarction
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Pleural effusion
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pathological fracture
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Pneumonia cytomegaloviral
1%
Femur fracture
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Gastroenteritis
1%
Humerus fracture
1%
Squamous cell carcinoma of skin
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)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Bortezomib + Dexamethasone (Vd)

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
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,522 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
745 Previous Clinical Trials
3,959,708 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
~7 spots leftby Jun 2024