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New drug cocktail aims to shorten dangerous low white blood cell period after transplant

NCT ID NCT05130827

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether adding plinabulin to the standard drug pegfilgrastim can shorten the time that white blood cell counts stay dangerously low after a stem cell transplant in people with multiple myeloma. Seventeen participants will receive both drugs right after their transplant. The main goal is to see how many days it takes for their white blood cells to recover, which could lower the risk of serious infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plinabulin and pegfilgrastim
What this could lead to
If it works, this combination could help multiple myeloma patients recover their white blood cell counts faster after a stem cell transplant, reducing infection risk.
What could go wrong
This is a small, early-phase pilot trial with only 17 participants, so results may not apply broadly. The drugs could also cause side effects like bone pain or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. LVEF ≥45% by MUGA or rest ECHO 2. Diffusion capacity \>45% (adjusted for hemoglobin) as predicted by pulmonary function testing * Clinical laboratory values meeting the following criteria within 14 days before enrollment: 1. Platelet count ≥ 20 x 109/L 2. ALT and AST ≤ 2.5 x ULN 3. Total bilirubin ≤ 2.5 x ULN; except if the elevation is due to Gilbert's syndrome 4. Calculated creatinine clearance \> 40 mL/min * All women of childbearing potential must: 1. Have a negative serum pregnancy test (β-human chorionic gonadotropin \[β-hCG\]) within 14 days prior to enrollment (and pre-AHCT per institutional guidelines) 2. 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) 3. For 180 days after receiving plinabulin, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction 4. 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 5. 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 Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

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

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

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