50 Participants NeededMy employer runs this trial

Daratumumab + Lenalidomide for Multiple Myeloma

VS
Overseen ByVanderbilt-Ingram Service Information Program
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eden Biltibo
Must be taking: Proteasome inhibitors, Immunomodulatory drugs
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for multiple myeloma, a type of blood cancer, using two drugs: daratumumab and lenalidomide. The researchers aim to determine if administering daratumumab less frequently, in combination with lenalidomide, remains effective and more cost-efficient for patients who have undergone a stem cell transplant. Daratumumab aids the immune system in killing cancer cells, while lenalidomide slows cancer growth. This trial may suit those with multiple myeloma who have received a stem cell transplant and seek maintenance therapy options. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

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 to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of daratumumab and lenalidomide is generally well-tolerated by patients with multiple myeloma. Several studies have found no new safety issues over time. Most patients experienced some side effects, and many cases reported serious ones. However, these side effects align with known treatment effects.

Daratumumab is approved for use with lenalidomide in various treatment settings, indicating an established level of safety. While side effects are common, they are usually manageable and expected based on previous research. Participants should discuss potential side effects with their healthcare provider.12345

Why are researchers excited about this study treatment for multiple myeloma?

Researchers are excited about the combination of Daratumumab and Lenalidomide for treating multiple myeloma because it offers a novel maintenance therapy approach. Unlike standard treatments that often involve intravenous administration, Daratumumab in this study is administered subcutaneously, which can be more convenient and comfortable for patients. Moreover, this combination leverages Daratumumab's ability to target CD38 on multiple myeloma cells, potentially enhancing the effectiveness of Lenalidomide. This innovative approach could improve patient outcomes by providing a more targeted and efficient therapy option.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Studies have shown that combining daratumumab with lenalidomide effectively treats multiple myeloma, a type of blood cancer. In one study, 89% of patients responded to the treatment, with some experiencing complete or very good partial improvements. Another study found a high response rate of 97.3%, with many patients experiencing significant tumor shrinkage. Research also indicates that this treatment can help patients live longer without disease progression. These results suggest that daratumumab and lenalidomide together offer a promising option for people with multiple myeloma. Participants in this trial will receive daratumumab and lenalidomide as part of the study's experimental treatment arm.12678

Who Is on the Research Team?

EB

Eden Biltibo, MD, PhD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with newly diagnosed multiple myeloma who have had a stem cell transplant and responded well to treatment. Participants must be in good general health, able to use birth control, and not have certain other cancers or serious medical conditions.

Inclusion Criteria

Compliance with pregnancy prevention measures
I am 18-70, newly diagnosed with multiple myeloma, had ASCT, and responded well to treatment.
I am fully active or can care for myself with little help.
See 7 more

Exclusion Criteria

All patients with concomitant amyloidosis or plasma cell leukemia
Participation in other investigational studies
I have specific medical conditions or treatments that may affect my eligibility.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Daratumumab-hyaluronidase is given every 8 weeks for the first year followed by every 16 weeks for years 2 through 4 in combination with lenalidomide

4 years
Visits every 8 weeks in year 1, every 16 weeks in years 2-4

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab and Recombinant Human Hyaluronidase
  • Lenalidomide

Trial Overview

The study tests giving Daratumumab-hyaluronidase (Darzalex Faspro) less often—every 8 weeks then every 16 weeks—combined with lenalidomide as maintenance therapy after stem cell transplant, aiming to see if this schedule works as well but costs less and requires fewer clinic visits.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Daratumumab + LenalidamideExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eden Biltibo

Lead Sponsor

Citations

Efficacy and Safety of Daratumumab, Lenalidomide ... - PMC

Treatment response was observed in 49 patients (89%), with 12 complete responses, 22 very good partial responses, and 15 partial responses. After a median ...

World Outcomes for Relapsed or Refractory Multiple Myeloma ...

Results: Of the 6915 L2 and L3 treated RRMM pts in the database, 1023 (14.8%) received Len and Dara sparing triplet regimens with 751 (10.9%) ...

Daratumumab, Bortezomib, Lenalidomide, and ...

The estimated percentage of patients with progression-free survival at 48 months was 84.3% in the D-VRd group and 67.7% in the VRd group (hazard ratio for ...

Combination Elranatamab, Daratumumab, Lenalidomide ...

The overall response rate was 97.3%, with 94.6% of patients having very good or partial responses and 27.0% having a complete response; the ...

Dr Badros on the Efficacy of Daratumumab Plus ...

In the intention-to-treat population, the daratumumab and lenalidomide combination yielded an MRD-negative conversion rate of 50.5% compared ...

Overall Survival With Daratumumab, Lenalidomide, and ...

Daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly prolonged progression-free survival versus lenalidomide and dexamethasone ( ...

Daratumumab/lenalidomide/dexamethasone in transplant- ...

No new safety concerns were observed with longer follow-up (Table 3). Grade 3/4 treatment-emergent AEs (TEAEs) were reported in 95.9% of ...

Daratumumab Improves Outcomes in Combination With ...

Daratumumab Improves Outcomes in Combination With Lenalidomide, Dexamethasone for Relapsed/Refractory Multiple Myeloma. Vicki Moore, PhD.