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Multiple MyelomaPhase 2NCT05130827

Study of Plinabulin and Pegfilgrastim in People With Multiple Myeloma Undergoing an Autologous Hematopoietic Stem Cell Transplant (AHCT)

A Phase 2 study testing Plinabulin in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Plinabulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
7 sitesUnited States
Study dates
21 Dec 2021to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic confirmation of multiple myeloma by the enrolling institution in patient undergoing autologous HCT with melphalan 140 or 200 mg/m^2
  • Age 18-75
  • Have at least 3 x 10^6 CD34+ autologous stem cells/kg to be infused
  • Karnofsky performance greater than or equal to 60 within 2 weeks prior to enrollment.
  • Organ function testing within 28 days before enrollment:
  • LVEF ≥45% by MUGA or rest ECHO
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  • Diffusion capacity >45% (adjusted for hemoglobin) as predicted by pulmonary function testing
  • Clinical laboratory values meeting the following criteria within 14 days before enrollment:
  • Platelet count ≥ 20 x 109/L
  • ALT and AST ≤ 2.5 x ULN
  • Total bilirubin ≤ 2.5 x ULN; except if the elevation is due to Gilbert's syndrome
  • Calculated creatinine clearance > 40 mL/min
  • All women of childbearing potential must:
  • Have a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) within 14 days prior to enrollment (and pre-AHCT per institutional guidelines)
  • For 180 days after receiving plinabulin practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject)
  • For 180 days after receiving plinabulin, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
  • Not of childbearing potential is defined as postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy
  • Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above.
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm for 180 days after receiving plinabulin

Who cannot join

  • Other malignancy within the past 2 years, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
  • Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B (Hep B) surface antigen positivity. Patients with Hep B Core Antibody positivity can be enrolled if the Hep B PCR is negative, and they are on antiviral suppression.
  • Patients with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate treatment at the time of enrollment.
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment
  • Had hospitalization for infection or major surgery (e.g., requiring general anesthesia) within 14 days before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate
  • A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 180 days after plinabulin
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  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the PI; or unwillingness or inability to follow the procedures required in the protocol.
  • Significant cardiovascular history:
  • History of myocardial infarction or ischemic heart disease within 1 year (within a window of up to 18 days less than 1 year) before study drug administration
  • Uncontrolled arrhythmia
  • History of congenital QT prolongation
  • Electrocardiogram (ECG) findings consistent with active ischemic heart disease
  • New York Heart Association Class III or IV cardiac disease;
  • Uncontrolled hypertension: blood pressure consistently >150 mm Hg systolic and > 100 mm Hg diastolic in spite of antihypertensive medication
  • Prior transient ischemic attack or cerebrovascular accident with in the past year (within an 18-day window). Any neurologic toxicities ≥ Grade 2 within 3 weeks of randomization.
  • History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable). History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility.
  • Known prior hypersensitivity reaction to any product containing polysorbate 80, polyoxyethylene 15-hydroxystearate/Macrogol 15 hydroxystearate (Solutol HS 15/Kolliphor HS 15).
  • Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include uncontrolled diabetes, infection requiring parenteral anti-infective treatment, liver failure, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent form.
  • Unwilling or unable to comply with procedures required in this protocol.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Rockville Centre, New York, 11553

Other trials in United States

About this study

Official title: Pilot Trial of Plinabulin and Pegfilgrastim to Reduce the Duration of Absolute Neutropenia After Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

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).

Being tested
Plinabulin
Keywords
Plinabulin, Pegfilgrastim, Autologous Hematopoietic Stem Cell Transplant (AHCT), 21-337
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlinabulinDrug

    40mg flat dose IV infusion, infused over approximately 30 minutes starting between 1-3 hours after stem cell infusion on day 0.

Study groups in NCT05130827
Study groupRoleWhat they receive
PlinabulinExperimentalIn 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.
Receives: Drug: Plinabulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average duration of absolute neutropenia

    defined as the number of days after treatment in which the absolute neutrophil count is less than 500 x 10^6/L.

    Measured: 1 year

Secondary outcomes (1)

  1. Incidence of toxicities

    CTCAE Version 5 will be utilized for toxicity evaluation.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start21 Dec 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a pilot trial investigating a single dose of plinabulin on day of stem cell infusion (Day 0) in conjunction with pegfilgrastim on Day +1 after autologous hematopoietic cell transplant (AHCT).
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130827
Sponsor's protocol ID
21-337
Status last verified
Dec 2025
First submitted
22 Nov 2021
Last updated
24 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plinabulin in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average duration of absolute neutropenia (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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