73 Participants Needed

Selinexor + DRd for Multiple Myeloma

Recruiting at 10 trial locations
SA
Overseen BySharan Aranha, BDS, MHA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: US Oncology Research
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
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-arm, phase II, open-label trial to investigate the effects of selinexor (S) in combination with daratumumab, lenalidomide, and dexamethasone (DRd) for first-line treatment of multiple myeloma (MM).FDA has approved selinexor plus dexamethasone in multiple myeloma after four prior therapies, and DRd is also already approved by the FDA for multiple myeloma. This study will use all four (S-DRd) together to treat MM as an initial treatment.

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

The trial protocol does not specify if you need to stop your current medications. However, since this is a first-line treatment for multiple myeloma, it's likely that you may need to adjust your current medications. Please consult with the trial investigators for specific guidance.

Do I need to stop my current medications to join 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 team or your doctor to get a clear answer.

What safety data exists for the treatment of Selinexor + DRd in multiple myeloma?

The combination of Selinexor, Daratumumab, and Dexamethasone (SDd) has been studied for safety in patients with relapsed or refractory multiple myeloma. In a study with 34 patients, common treatment-related adverse events included thrombocytopenia (70.6%), nausea (70.6%), fatigue (61.8%), anemia (61.8%), and neutropenia (50.0%). The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for Selinexor was determined to be 100 mg once weekly. The treatment was generally well tolerated, with no dose-limiting toxicities reported at this dose. Other studies have shown that Selinexor, when combined with other agents like bortezomib and dexamethasone, has a predictable toxicity profile, with common side effects including thrombocytopenia, anemia, neutropenia, fatigue, nausea, anorexia, and weight loss. These side effects are significant but manageable with aggressive and preemptive care.12345

What is the safety profile of Selinexor combined with Daratumumab and Dexamethasone for treating multiple myeloma?

The combination of Selinexor, Daratumumab, and Dexamethasone has been studied for safety in patients with relapsed or refractory multiple myeloma. Common side effects include low platelet counts (thrombocytopenia), nausea, fatigue, low red blood cell counts (anemia), and low white blood cell counts (neutropenia). The treatment was generally well tolerated, with no unexpected side effects reported.12345

Is the drug combination of Selinexor, Daratumumab, Dexamethasone, and Lenalidomide promising for treating Multiple Myeloma?

Yes, the combination of Selinexor, Daratumumab, Dexamethasone, and Lenalidomide shows promise for treating Multiple Myeloma. It has a high overall response rate of 73% in patients who haven't been treated with Daratumumab before, and it helps patients live longer without the disease getting worse for about 12.5 months. This suggests it could be a valuable option for patients who have tried other treatments.12346

What makes the drug Selinexor + DRd unique for treating multiple myeloma?

The Selinexor + DRd treatment is unique because it combines selinexor, an oral selective inhibitor of nuclear export, with daratumumab and dexamethasone, offering a novel approach for patients with relapsed or refractory multiple myeloma who are resistant to other treatments. This combination is particularly promising for patients whose disease is naïve to daratumumab, showing a high overall response rate and progression-free survival.12346

What data supports the idea that Selinexor + DRd for Multiple Myeloma is an effective drug?

The available research shows that the combination of Selinexor with Daratumumab and Dexamethasone (SDd) is effective for treating multiple myeloma. In a study with 34 patients, 73% of them responded positively to the treatment, and those who had not previously been treated with Daratumumab had a median time of 12.5 months before the disease worsened. This suggests that the combination is promising, especially for patients who have tried other treatments without success. Compared to another combination involving Selinexor, Bortezomib, and Dexamethasone (SVd), which had a 63% response rate, the SDd combination shows a higher response rate, indicating its potential effectiveness.12346

What data supports the effectiveness of the drug combination Selinexor, Daratumumab, and Dexamethasone for treating multiple myeloma?

Research shows that the combination of Selinexor, Daratumumab, and Dexamethasone has a promising overall response rate of 73% in patients with relapsed or refractory multiple myeloma who have not previously been treated with Daratumumab. This suggests that the drug combination can be effective in controlling the disease.12346

Who Is on the Research Team?

RM

Robert M Rifkin, MD, FACP

Principal Investigator

US Oncology Research/McKesson Specialty Health

Are You a Good Fit for This Trial?

Adults with untreated multiple myeloma can join this trial. They must be able to follow the study plan and use effective birth control if they can have children. People who've had major surgery recently, have brain involvement by myeloma, HIV, hepatitis B or C, serious heart issues, or certain blood conditions cannot participate.

Inclusion Criteria

I am able to care for myself and perform daily activities.
You have a detectable disease that meets certain standards.
My myeloma has not been treated before.
See 5 more

Exclusion Criteria

I do not have any health conditions that could affect the study.
You are thinking about getting pregnant.
My multiple myeloma has affected my brain or spinal cord.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Selinexor in combination with daratumumab, lenalidomide, and dexamethasone for first-line treatment of multiple myeloma

6 months
Weekly visits for the first 2 cycles, bi-weekly visits for cycles 3-6, and monthly visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab
  • Dexamethasone Oral
  • Lenalidomide
  • Selinexor
Trial Overview The trial is testing a combination of four drugs: Selinexor plus Daratumumab, Lenalidomide, and Dexamethasone (S-DRd) as a first-line treatment for multiple myeloma. It's an open-label phase II study where everyone gets the same treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Selinexor plus DRdExperimental Treatment4 Interventions

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

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

US Oncology Research

Lead Sponsor

Trials
38
Recruited
17,400+

Karyopharm Therapeutics Inc

Industry Sponsor

Trials
89
Recruited
7,200+

Richard Paulson

Karyopharm Therapeutics Inc

Chief Executive Officer since 2021

MBA from the University of Toronto's Rotman School of Management

Reshma Rangwala

Karyopharm Therapeutics Inc

Chief Medical Officer since 2023

MD, PhD

Published Research Related to This Trial

In a study of 34 patients with relapsed refractory multiple myeloma, the combination of selinexor, daratumumab, and dexamethasone showed a promising overall response rate of 73% and a median progression-free survival of 12.5 months in patients who had not previously received daratumumab.
The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for selinexor was determined to be 100 mg once weekly, with common side effects including thrombocytopenia and nausea, indicating that the treatment regimen is generally well tolerated.
Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma.Gasparetto, C., Lentzsch, S., Schiller, G., et al.[2022]
Selinexor, when combined with low-dose bortezomib and dexamethasone, showed a 63% overall response rate in treating relapsed or refractory multiple myeloma, with particularly high efficacy in patients not previously resistant to proteasome inhibitors (84% response rate).
The treatment was generally well-tolerated, with the most common severe side effects being thrombocytopenia (45%) and neutropenia (24%), while the recommended phase 2 dose was established as selinexor 100 mg once weekly, bortezomib 1.3 mg/m2 once weekly, and dexamethasone 40 mg once weekly.
Selinexor plus low-dose bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma.Bahlis, NJ., Sutherland, H., White, D., et al.[2021]
Selinexor, when used in combination with dexamethasone or bortezomib and dexamethasone, showed an overall response rate of 29.5% in 44 patients with relapsed or refractory myeloma, indicating its efficacy as a treatment option.
The most common side effects included fatigue and thrombocytopenia, with 56% of patients requiring dose reductions; however, these adjustments did not negatively impact progression-free survival, suggesting that selinexor can be managed safely in clinical practice.
Real World Efficacy and Toxicity of Selinexor: Importance of Patient Characteristics, Dose Intensity and Post Progression Outcomes.Kastritis, E., Gavriatopoulou, M., Solia, E., et al.[2023]

Citations

Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma. [2022]
Selinexor plus low-dose bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma. [2021]
Real World Efficacy and Toxicity of Selinexor: Importance of Patient Characteristics, Dose Intensity and Post Progression Outcomes. [2023]
Targeting Nuclear Export Proteins in Multiple Myeloma Therapy. [2022]
Phase 1 study of selinexor plus carfilzomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma. [2023]
Safety and efficacy of selinexor in relapsed or refractory multiple myeloma and Waldenstrom macroglobulinemia. [2021]
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