A Phase 3 interventional study of Fosaprepitant and Fosaprepitant in Multiple Myeloma, sponsored by The Affiliated People's Hospital of Ningbo University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 3, Interventional, and Treatment
This study employs a prospective, multicenter, randomized, two-arm design aimed at evaluating the efficacy and safety of the FTO regimen in preventing delayed chemotherapy-induced nausea and vomiting (CINV) following high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT). A total of 92 patients with multiple myeloma who were indicated for autologous HSCT were enrolled. The primary endpoint was to compare the complete response (CR) rates of the FTO regimen versus the FTD regimen in the delayed phase (24-240 hours after chemotherapy) for preventing nausea and vomiting induced by high-dose chemotherapy during HSCT.
Based on strict inclusion and exclusion criteria, 92 patients with multiple myeloma from 11 hospitals were enrolled. Eligible subjects were randomly assigned in a 1:1 ratio to either the experimental group (FTO regimen) or the control group (FTD regimen).The FTO regimen was administered as follows:Fosaprepitant 150 mg (intravenously every 72 hours starting from the initiation of preconditioning chemotherapy until day +6 after HSCT),Tropisetron 5 mg (intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2),Olanzapine 5 mg (orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurred first).The FTD regimen was administered as follows: Fosaprepitant 150 mg (intravenously 30 minutes before chemotherapy on day -3),Tropisetron 5 mg (intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2),Dexamethasone 6 mg (orally 30 minutes before chemotherapy on day -3),and 3.75 mg (orally on days -2 to 0).
The study compared the complete response (CR) rates of the FTO regimen versus the FTD regimen during the acute phase (preconditioning chemotherapy period and 0-24 hours after chemotherapy) and the overall phase (preconditioning chemotherapy period and 0-240 hours after chemotherapy). It also observed and compared the major response (MR), clinical benefit response (CBR), minor response (MiR), and treatment failure (TF) between the two regimens during the acute, delayed, and overall phases. Additionally, the toxic side effects of the FTO and FTD regimens were observed and compared.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 92 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →The Affiliated People's Hospital of Ningbo University is the lead sponsor of 10 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fosaprepitant, Tropisetron and Olanzapine.
Drug: Fosaprepitant · Drug: Tropisetron · Drug: Olanzapine
Fosaprepitant, Tropisetron and Dexamethasone.
Drug: Fosaprepitant · Drug: Tropisetron · Drug: Dexamethasone
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
150mg, intravenously 30 minutes before chemotherapy on day -3
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
5mg, orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurs first
6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0
Complete Response (CR)
No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.
Time frame: 24 to 240 hours after chemotherapy
Major Response (MR)
No vomiting with severe nausea (scoring 8-10 on the MASCC Antiemesis Tool), and no rescue medication use.
Time frame: 0-240 hours after chemotherapy
Clinical Benefit Response (CBR)
CR+MR.
Time frame: 0-240 hours after chemotherapy
Minor Response (MiR)
No more than 1-2 vomiting episodes per day, but vomiting occurring on no more than 3 days during the assessment period, with or without nausea of any severity, with permissible use of rescue medication.
Time frame: 0-240 hours after chemotherapy
Treatment Failure (TF)
More than 2 vomiting episodes on any day during the assessment period, or more than 1 vomiting episode per day on 3 or more days during the assessment period.
Time frame: 0-240 hours after chemotherapy
Toxic Side Effects
Toxicity and adverse reaction assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: 0-240 hours after chemotherapy
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2027, 23 months after the start.
Of 71 non-industry phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 87 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 108. This study's planned 23 months is below that.
Counting every sponsor, half of 178 studies reached it within 56 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Olanzapine
The Affiliated People's Hospital of Ningbo University