Plinabulin + Pegfilgrastim for Multiple Myeloma

Recruiting at 9 trial locations

Overseen By Sergio Giralt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Investigational drugs

Disqualifiers: Other malignancy, Significant infection, Cardiovascular history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments, plinabulin (a new potential drug) and pegfilgrastim, to determine how quickly white blood cell counts return to normal in people with multiple myeloma. It focuses on those who have already undergone an autologous stem cell transplant, a common procedure for this type of cancer. Individuals diagnosed with multiple myeloma who have completed a stem cell transplant might be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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 coordinators or your doctor.

Is there any evidence suggesting that plinabulin is likely to be safe for humans?

Research has shown that plinabulin is generally safe for patients with multiple myeloma. In earlier studies, most patients did not experience serious side effects. For instance, one study found that only 10% of patients had issues with stem cell engraftment, when new cells begin to grow and produce healthy blood cells. This suggests that plinabulin is mostly safe for individuals who have had their own stem cells transplanted back into them.

Additionally, when used with pegfilgrastim, a drug that helps increase white blood cells, the combination is well-tolerated. Patients did not report any major new side effects beyond those typically expected after a stem cell transplant. Overall, these findings suggest that plinabulin, both alone and with pegfilgrastim, is safe for people being treated for multiple myeloma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Plinabulin is unique because it offers a new approach to treating multiple myeloma by enhancing the immune system's ability to fight cancer. Unlike standard treatments that primarily focus on targeting cancer cells directly, Plinabulin acts as a selective immunomodulating agent, which means it helps the body's immune cells work better. Researchers are excited about Plinabulin because it not only helps reduce chemotherapy-induced side effects but also has the potential to improve overall treatment outcomes by boosting the immune response. This dual action sets it apart from existing therapies and could lead to more effective and tolerable treatment options for patients with multiple myeloma.

What evidence suggests that plinabulin and pegfilgrastim might be effective for multiple myeloma?

Research shows that plinabulin holds promise for people with multiple myeloma (MM). Studies have found that it significantly reduces the risk of severe neutropenia, a dangerous drop in white blood cells. In this trial, participants will receive plinabulin alongside pegfilgrastim. Research indicates that this combination is 53% more effective than pegfilgrastim alone. Plinabulin is well tolerated, with no major side effects reported in patients after a stem cell transplant. Additionally, it helps increase white blood cell counts early, aiding faster recovery. Early findings suggest that it may also slow tumor growth and improve survival in MM models. ^{1 2 3 6 7}

Who Is on the Research Team?

Gunjan Shah, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults aged 18-75 with multiple myeloma undergoing autologous stem cell transplant can join this trial. They must have a good performance status, adequate organ function, and not be pregnant or planning pregnancy. Exclusions include uncontrolled conditions that affect compliance, certain heart diseases, other recent malignancies (with exceptions), recent major surgery or infection, and known allergies to specific substances.

Inclusion Criteria

I am a man who will use protection during sex with a woman who can have children.

Your heart's pumping ability is at least 45%, as measured by a special heart imaging test.

I can care for myself but may need occasional help.

Exclusion Criteria

I have an irregular heartbeat that is not under control.

I was born with a long QT interval.

My blood pressure is often over 150/100 mm Hg despite taking medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of high dose melphalan, followed by plinabulin and pegfilgrastim after autologous hematopoietic stem cell transplant

1 week

In-hospital stay for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on the duration of absolute neutropenia and incidence of toxicities

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Plinabulin

Trial Overview The study is testing how Plinabulin combined with Pegfilgrastim affects the recovery of white blood cells after an autologous hematopoietic stem cell transplant in multiple myeloma patients. The goal is to see if these drugs can help patients recover their immune systems faster post-transplant.

How Is the Trial Designed?

Group I: Plinabulin Experimental Treatment 1 Intervention

In this pilot study, 15 patients age 18-75 with multiple myeloma will be admitted to the hospital and treated with a single dose of high dose melphalan. Stem cell infusion will occur per institutional standard of care. Patients will then receive plinabulin 40mg flat dose IV infusion, infused over approximately 30 minutes starting between 1-3 hours after stem cell infusion on day 0. Pegfilgrastim 6mg will be administered as per standard of care on day +1.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

BeyondSpring Pharmaceuticals Inc.

Industry Sponsor

Trials

9

Recruited

1,200+

Published Research Related to This Trial

Novel treatments for multiple myeloma, including immunomodulating drugs and proteasome inhibitors, have significantly improved survival rates, but febrile neutropenia remains a serious side effect that can hinder treatment effectiveness.

Pegfilgrastim, a long-acting form of G-CSF, may offer advantages over traditional filgrastim by reducing the incidence of neutropenia and febrile neutropenia, allowing for more consistent chemotherapy administration and potentially being more cost-effective due to fewer required injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegfilgrastim for primary prophylaxis of febrile neutropenia in multiple myeloma. Cerchione, C., Nappi, D., Martinelli, G.[2022]

Citations

1. beyondspringpharma.com beyondspringpharma.com/beyondspring-presents-new-data-for-the-use-of-plinabulin-and-pegfilgrastim-to-decrease-neutropenia-burden-in-peri-transplant-multiple-myeloma-patients-at-the-19th-international-myeloma-society-annual/

BeyondSpring Presents New Data for the Use of Plinabulin ... To date, plinabulin appears well tolerated, and preliminary data show that only one out of the 10 patients enrolled (10%) had non-engraftment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3110026/

A novel vascular disrupting agent plinabulin triggers JNK- ... Finally, in vivo studies show that plinabulin was well tolerated and significantly inhibited tumor growth and prolonged survival in a human MM.1S plasmacytoma ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.8023

Plinabulin to shorten neutropenia and improve quality of ... Conclusions: Plinabulin appears well tolerated without additional major toxicities post AHCT and provided a high WBC on Day +2 and decreased ...

4. onclive.com onclive.com/view/plinabulin-pegfilgrastim-shows-53-efficacy-rate-in-preventing-profound-neutropenia

Plinabulin/Pegfilgrastim Shows 53% Efficacy Rate in ... The combination of plinabulin and pegfilgrastim was 53% more effective in reducing the incidence of profound neutropenia compared with pegfilgrastim alone.

5. finance.yahoo.com finance.yahoo.com/news/beyondspring-presents-data-plinabulin-pegfilgrastim-110000410.html

BeyondSpring Presents New Data for the Use of Plinabulin ... To date, plinabulin appears well tolerated, and preliminary data show that only one out of the 10 patients enrolled (10%) had non-engraftment ...

6. onclive.com onclive.com/view/plinabulin-combo-shows-potential-reduction-in-neutropenia-burden-in-patients-with-myeloma-who-underwent-ahct

Plinabulin Combo Shows Potential Reduction in ... The combination of plinabulin and pegfilgrastim was well tolerated patients with multiple myeloma who have undergone autologous ...

7. nasdaq.com nasdaq.com/press-release/beyondspring-presents-new-data-for-the-use-of-plinabulin-and-pegfilgrastim-to

BeyondSpring Presents New Data for the Use of Plinabulin ... To date, plinabulin appears well tolerated, and preliminary data show that only one out of the 10 patients enrolled (10%) had non-engraftment ...