Plinabulin + Pegfilgrastim for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+9 other locations

Gunjan L. Shah, MD - MSK Bone Marrow ...

Overseen byGunjan Shah, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

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).

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.

See 11 more

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.

See 15 more

Treatment Details

Interventions

Plinabulin (Vascular Disrupting Agent)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: PlinabulinExperimental Treatment1 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.