200 Participants Needed

Daratumumab + Lenalidomide for Multiple Myeloma

(AURIGA Trial)

Recruiting at 87 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Must be taking: Lenalidomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of Daratumumab and Lenalidomide safe for treating multiple myeloma?

The combination of Daratumumab and Lenalidomide, often used with Dexamethasone, has been shown to be generally safe for treating multiple myeloma, with common side effects including low blood cell counts, nerve damage, and infections. No new safety concerns have been identified in recent studies.12345

What makes the drug combination of Daratumumab and Lenalidomide unique for treating multiple myeloma?

This drug combination is unique because it combines Daratumumab, a monoclonal antibody that targets and kills myeloma cells, with Lenalidomide, an immunomodulatory drug, enhancing the immune system's ability to fight the cancer. This combination has shown to improve progression-free survival and overall response rates in patients with multiple myeloma compared to standard treatments.13678

What data supports the effectiveness of the drug combination Daratumumab and Lenalidomide for treating multiple myeloma?

Research shows that adding Daratumumab to Lenalidomide and Dexamethasone significantly improves the response rate in patients with multiple myeloma, with more patients achieving a partial response or better compared to those not receiving Daratumumab.3691011

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have remaining cancer cells detected by a specific blood test.
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.
I have bone marrow samples or MRD test results from before my treatment.
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Exclusion Criteria

You have a known history of testing positive for HIV, hepatitis B, or hepatitis C, unless you have been vaccinated for hepatitis B or have successfully cleared hepatitis C virus from your body.
I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.
I have not had Daratumumab or similar treatments, recent radiation (except for symptom relief), or plasmapheresis in the last 28 days.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daratumumab plus lenalidomide or lenalidomide alone as maintenance therapy for a maximum of 36 cycles

36 months
Monthly visits for each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab
  • Lenalidomide
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Daratumumab + LenalidomideExperimental Treatment2 Interventions
Group II: LenalidomideActive Control1 Intervention

Lenalidomide is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Revlimid for:
🇺🇸
Approved in United States as Revlimid for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study of 737 patients with newly diagnosed multiple myeloma, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of disease progression or death, with a hazard ratio of 0.56, indicating a 44% lower risk compared to the control group.
Patients receiving daratumumab had a higher rate of complete response (47.6% vs. 24.9%) and a greater percentage achieving minimal residual disease status (24.2% vs. 7.3%), although they also experienced more severe side effects like neutropenia and pneumonia.
Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma.Facon, T., Kumar, S., Plesner, T., et al.[2023]
The combination therapy of carfilzomib, lenalidomide, dexamethasone, and daratumumab achieved a high minimal residual disease (MRD) negativity rate of 71% in newly diagnosed multiple myeloma patients, indicating effective treatment without the need for high-dose melphalan chemotherapy or autologous transplant.
The treatment demonstrated excellent safety and tolerability, with a 1-year progression-free survival rate of 98% and no reported deaths, although some patients experienced grade 3 or 4 adverse events like neutropenia and rash.
Safety and Effectiveness of Weekly Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma: The MANHATTAN Nonrandomized Clinical Trial.Landgren, O., Hultcrantz, M., Diamond, B., et al.[2022]
Combining lenalidomide with daratumumab significantly enhances the ability of the immune system to kill multiple myeloma cells, as shown in assays using both cell lines and primary patient cells.
The synergy between lenalidomide and daratumumab was particularly evident in the bone marrow environment of multiple myeloma patients, suggesting that this combination could be a powerful treatment strategy in clinical settings.
Towards effective immunotherapy of myeloma: enhanced elimination of myeloma cells by combination of lenalidomide with the human CD38 monoclonal antibody daratumumab.van der Veer, MS., de Weers, M., van Kessel, B., et al.[2021]

Citations

Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. [2023]
Safety and Effectiveness of Weekly Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma: The MANHATTAN Nonrandomized Clinical Trial. [2022]
Towards effective immunotherapy of myeloma: enhanced elimination of myeloma cells by combination of lenalidomide with the human CD38 monoclonal antibody daratumumab. [2021]
Daratumumab with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma patients - real world evidence analysis. [2023]
Outcome of carfilzomib/pomalidomide-based regimens after daratumumab-based treatment in relapsed multiple myeloma: A Canadian Myeloma Research Group Database analysis. [2023]
Daratumumab combined with dexamethasone and lenalidomide or bortezomib in relapsed/refractory multiple myeloma (RRMM) patients: Report from the multiple myeloma GIMEMA Lazio group. [2022]
Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX. [2019]
Daratumumab for the Treatment of Multiple Myeloma: A Review of Clinical Applicability and Operational Considerations. [2022]
Efficacy and safety of daratumumab in the treatment of multiple myeloma: a systematic review and meta-analysis. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. [2022]
Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. [2021]
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