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Plinabulin + Pegfilgrastim for Multiple Myeloma
Study Summary
This trial will look at how long it takes for white blood cell counts to go back to normal in MM patients who get plinabulin & pegfilgrastim after having an AHCT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an irregular heartbeat that is not under control.I am a man who will use protection during sex with a woman who can have children.I was born with a long QT interval.My blood pressure is often over 150/100 mm Hg despite taking medication.Your heart's pumping ability is at least 45%, as measured by a special heart imaging test.My heart condition severely limits my daily activities.I haven't had cancer in the last 2 years, except for certain skin or early-stage cervical cancers.I can care for myself but may need occasional help.I have enough stem cells for a transplant.You have had a bad reaction to a product containing polysorbate 80 or polyoxyethylene 15-hydroxystearate.You have signs of heart disease on an electrocardiogram (ECG).I haven't used any experimental drugs or devices in the last 14 days.Your lung function, measured by a breathing test, is more than 45% of what is expected for someone with your level of hemoglobin.Your total bilirubin level should be within a certain range, unless it's high due to Gilbert's syndrome.My multiple myeloma diagnosis has been confirmed and I am undergoing a specific stem cell transplant.I have a history of severe diarrhea, bowel inflammation, or uncontrolled stomach ulcers.I have not had a stroke or mini-stroke in the last year and no severe nerve damage in the last 3 weeks.I haven't had a heart attack or heart disease in the last year.I cannot become pregnant due to age, surgery, or other medical reasons.Women who could become pregnant must have a negative pregnancy test within 14 days before joining the study.I haven't been hospitalized for an infection or had major surgery in the last 14 days.I am between 18 and 75 years old.Your blood platelet count is at least 20 billion per liter.Your liver enzymes (ALT and AST) should be within a certain range.I do not have any significant infections, including HIV or active hepatitis.I have an infection that hasn't improved with treatment.My kidneys are functioning well enough to clear waste.
- Group 1: Plinabulin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other experiments have occurred involving Plinabulin?
"Plinabulin's first clinical trial was conducted by Rutgers Cancer Institute of New jersey in 2018. Thus far, 6 completed trials have been reported and 4 more are ongoing at multiple locations throughout Basking Ridge, NY."
Are there any openings to join this clinical experiment at present?
"Affirmative. As evidenced by clinicaltrials.gov, this trial is actively recruiting participants after being initially posted on December 21st 2021 and last updated October 10th 2022. 16 individuals need to be enrolled from 7 different medical locations."
Does this research initiative accept individuals below the age of 30?
"Participants for this study must be over the age of consent and below 75 years old. For individuals younger than 18, there are 40 different studies available, whereas 797 clinical trials exist for seniors aged 65 or above."
How many medical facilities are currently engaged in this trial?
"At present, patients can enroll in the study at Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities),Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) and Memoral Sloan Kettering Westchester (Limited Protocol Activities). There are also 7 other sites that accept participants."
Is this experiment the inaugural one of its type?
"Initially researched in 2018 by Bristol-Myers Squibb, Plinabulin has since been approved for Phase 1 & 2 drug trials. Currently there are 4 active clinical studies involving the medication across 22 cities and 3 countries worldwide."
Has Plinabulin received the official endorsement of the FDA?
"With only a few experiments conducted on Plinabulin's safety, it received an estimated score of 2. No data has been collected that supports its efficacy in treating patients."
Do I meet the prerequisites to participate in this clinical study?
"This clinical research is looking for 16 volunteers aged 18 to 75 with multiple myeloma, who also meet the heart health requirements of left ventricular ejection fraction ≥45%."
How many participants are being accepted into this clinical research?
"Indeed, information posted on clinicaltrials.gov reveals that this medical trial is recruiting patients. It was initially advertised on December 21st 2021 and recently modified on October 10th 2022. The study requires 16 participants to be recruited from 7 distinct locations."
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