95 Participants Needed

Daratumumab vs Lenalidomide for Multiple Myeloma

Recruiting at 9 trial locations
US
UA
Sham Mailankody, MD profile photo
Overseen BySham Mailankody, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Anticoagulants, Antivirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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?

The purpose of this study is to compare maintenance therapy approaches in people with newly diagnosed multiple myeloma (MM) that has responded well to a first round of treatment. The researchers will compare giving the usual maintenance therapy (lenalidomide) with giving daratumumab as maintenance therapy, and they will look at which drug gives participants a better health-related quality of life during treatment. The researchers will measure participants' quality of life using various questionnaires. This study will help researchers find out whether this different approach of giving daratumumab as maintenance therapy is better, the same as, or worse than the usual approach.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to take daily preventive medications for blood clots and viral infections, like aspirin and acyclovir.

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

The combination of Daratumumab and Lenalidomide is generally considered safe for treating multiple myeloma, with common side effects including low blood cell counts, nerve damage, and infections.12345

What makes the drug Lenalidomide unique for treating multiple myeloma?

Lenalidomide, when combined with daratumumab and dexamethasone, offers a unique treatment option for multiple myeloma by enhancing the immune system's ability to fight cancer cells, leading to improved progression-free survival rates compared to other standard treatments.14678

What data supports the effectiveness of the drug Daratumumab when used with Lenalidomide for treating multiple myeloma?

Research shows that combining Daratumumab with Lenalidomide and Dexamethasone significantly improves patient outcomes, with a higher response rate and longer progression-free survival (time without the disease getting worse) compared to using Lenalidomide and Dexamethasone alone.134910

Who Is on the Research Team?

Urvi A. Shah, MD - MSK Myeloma Specialist

Urvi Shah, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with newly diagnosed multiple myeloma who've responded well to initial treatment. They must be able to take antiviral and anticoagulation meds, understand the consent form, and women of childbearing age must avoid pregnancy and adhere to REMS program requirements. Participants should have proper kidney, liver function, and agree to birth control measures.

Inclusion Criteria

Your platelet count is at least 50,000 per microliter.
I had a stem cell transplant over 100 days ago.
I agree not to donate eggs/sperm for 3 months after stopping daratumumab.
See 23 more

Exclusion Criteria

I am not participating in the nutrition sub-study.
I do not have any uncontrolled illnesses or social situations that would affect my study participation.
My condition did not improve or worsened while on lenalidomide or daratumumab.
See 28 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either daratumumab or lenalidomide as maintenance therapy. Daratumumab is administered as a subcutaneous injection, and lenalidomide is taken orally.

36 cycles (each cycle is 28 days)
Multiple visits per cycle as per drug administration schedule

Sub-study (optional)

Participants may opt into a sub-study involving a whole food plant-based diet and nutrition counseling for 12 weeks.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with quality of life questionnaires collected at therapy discontinuation and 1-month post therapy.

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab
  • Lenalidomide
Trial Overview The study compares usual maintenance therapy (lenalidomide) with daratumumab as a new option for maintaining health in multiple myeloma patients post-treatment. Quality of life will be assessed through questionnaires to determine if daratumumab offers better outcomes than lenalidomide.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Lenalidomide maintenanceExperimental Treatment3 Interventions
Group II: Daratumumab maintenanceExperimental Treatment3 Interventions

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?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials
165
Recruited
579,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Scientific Affairs, 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 Scientific Affairs, LLC

Chief Medical Officer since 2014

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

Published Research Related to This Trial

Daratumumab, when combined with lenalidomide and dexamethasone (DRd) or bortezomib and dexamethasone (DVd), showed an overall response rate of 80% in 171 heavily treated patients with relapsed/refractory multiple myeloma, indicating its efficacy in this challenging patient population.
Patients receiving the DRd combination experienced better progression-free survival (PFS) compared to those on DVd, with PFS rates of 84% and 77%, respectively, while the treatment was generally safe, with common side effects including neutropenia and infections.
Daratumumab combined with dexamethasone and lenalidomide or bortezomib in relapsed/refractory multiple myeloma (RRMM) patients: Report from the multiple myeloma GIMEMA Lazio group.Fazio, F., Franceschini, L., Tomarchio, V., et al.[2022]
In a study of 178 multiple myeloma patients who progressed after daratumumab treatment, the median progression-free survival (PFS) was only 4.5 months and overall survival (OS) was 14.2 months, indicating limited effectiveness of subsequent therapies.
Patients receiving pomalidomide-based therapy had a slightly better median PFS and OS (5.2 months and 21.7 months, respectively) compared to those on carfilzomib-based therapy, highlighting the need for new treatment options for patients previously treated with daratumumab.
Outcome of carfilzomib/pomalidomide-based regimens after daratumumab-based treatment in relapsed multiple myeloma: A Canadian Myeloma Research Group Database analysis.LeBlanc, R., Mian, H., Reece, D., et al.[2023]
Daratumumab, a monoclonal antibody targeting CD38, shows significantly improved overall survival in patients with multiple myeloma who have undergone extensive prior treatments, with an adjusted overall survival-hazard ratio of 0.33 based on a study of 148 patients compared to historical controls.
The study highlights that daratumumab is particularly effective in heavily pretreated patients, including those who are triple or quadruple refractory to other therapies, indicating its potential as a critical treatment option in advanced multiple myeloma cases.
Daratumumab monotherapy compared with historical control data in heavily pretreated and highly refractory patients with multiple myeloma: An adjusted treatment comparison.Usmani, SZ., Diels, J., Ito, T., et al.[2021]

Citations

Daratumumab combined with dexamethasone and lenalidomide or bortezomib in relapsed/refractory multiple myeloma (RRMM) patients: Report from the multiple myeloma GIMEMA Lazio group. [2022]
Outcome of carfilzomib/pomalidomide-based regimens after daratumumab-based treatment in relapsed multiple myeloma: A Canadian Myeloma Research Group Database analysis. [2023]
Daratumumab monotherapy compared with historical control data in heavily pretreated and highly refractory patients with multiple myeloma: An adjusted treatment comparison. [2021]
Daratumumab with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma patients - real world evidence analysis. [2023]
Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. [2023]
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]
Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. [2022]
Daratumumab-lenalidomide and daratumumab-pomalidomide in relapsed lenalidomide-exposed or refractory multiple myeloma. [2023]
EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. [2020]
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