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

Trial Summary

What is the purpose of this trial?

This study will see how long it takes for white blood cell counts to return to normal in people with multiple myeloma (MM) who receive plinabulin and pegfilgrastim after undergoing an autologous hematopoietic stem cell transplant (AHCT).

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.

How does the drug Plinabulin + Pegfilgrastim differ from other treatments for multiple myeloma?

The combination of Plinabulin and Pegfilgrastim is unique because it combines a novel agent with a long-acting form of a supportive care drug to potentially reduce the risk of febrile neutropenia (a dangerous drop in white blood cells) during chemotherapy for multiple myeloma. Pegfilgrastim, with its extended half-life, allows for less frequent dosing compared to traditional treatments, which may improve patient convenience and adherence. ^{1 2 3 4 5}

Research Team

Gunjan Shah, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pegfilgrastim for primary prophylaxis of febrile neutropenia in multiple myeloma. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Sustained G-CSF plasma levels following administration of pegfilgrastim fasten neutrophil reconstitution after high-dose chemotherapy and autologous blood stem cell transplantation in patients with multiple myeloma. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Pegylated Filgrastim Versus Filgrastim for Stem Cell Mobilization in Multiple Myeloma After Novel Agent Induction. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pegfilgrastim. [2018]