Study on Plinabulin and Pegfilgrastim for People with Multiple Myeloma Undergoing Stem Cell Transplant

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT05130827

This clinical trial is examining how quickly white blood cell counts return to normal in people with multiple myeloma who receive plinabulin and pegfilgrastim after a stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to find out how long it takes for white blood cell counts to recover in patients with multiple myeloma who are treated with plinabulin and pegfilgrastim following an autologous hematopoietic stem cell transplant (AHCT).

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple myeloma and undergoing a stem cell transplant with melphalan.
  • Aged between 18 and 75 years.
  • Have enough stem cells available for the transplant.
  • Have a performance status score of 60 or higher, indicating the ability to carry out daily activities.
  • Meet specific organ function requirements based on heart and lung tests.
  • Meet certain blood test criteria, including platelet count and liver and kidney function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and for 180 days after treatment.
  • Men must agree to use birth control and not donate sperm for 180 days after treatment.

Exclusion Criteria

  • Have had another cancer within the past 2 years, except for certain treated skin or cervical cancers.
  • Have a significant infection, including HIV or hepatitis C, or active hepatitis B.
  • Have uncontrolled infections despite treatment.
  • Have taken an investigational drug or used an investigational device recently.
  • Have been hospitalized for infection or major surgery recently.
  • Are pregnant, breastfeeding, or planning to become pregnant or father a child during or shortly after the study.
  • Have uncontrolled medical or psychological conditions that prevent following the study protocol.
  • Have significant heart problems, such as a recent heart attack or uncontrolled high blood pressure.
  • Have had a stroke or significant neurological issues recently.
  • Have certain gastrointestinal disorders or allergies to specific substances.
  • Have any medical conditions that pose excessive risk, as judged by the study doctor.
  • Are unwilling or unable to follow the study procedures.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited protocol activities)11553Rockville CentreNew York

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