Multiple MyelomaPhase 3NCT07413809
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
A Phase 3 study testing Fosaprepitant, Tropisetron and Olanzapine in people with Multiple Myeloma, run by The Affiliated People's Hospital of Ningbo University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Fosaprepitant, Tropisetron and Olanzapine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2025to Sep 2027
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation;
- Preconditioning regimen consists of melphalan at a dose of 200 mg/m²;
- ECOG performance status score of 0 to 2;
- Age >18 years and <65 years;
- Expected survival time >3 months;
- Absence of intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting;
- Ability to understand and provide written informed consent.
Who cannot join
- Presence of nausea or vomiting within 48 hours prior to enrollment, with prior use of antiemetic medications;
- Current use or use within the past month of CYP3A4 inducers, inhibitors, or substrate drugs;
- History of hypersensitivity to fosaprepitant or olanzapine;
- Serum creatinine clearance <60 mL/min;
- Inability to receive treatment and follow-up at the designated study site, or inability to comprehend, comply with the study protocol, or provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang
Peipei Ye, 86-13685832706, 39612903@qq.com
Ying Lu, 86-13486090834, 814871416@qq.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of Fosaprepitant Combined With Tropisetron and Multi-Day Olanzapine Versus Fosaprepitant Combined With Tropisetron and Dexamethasone for the Prevention of Delayed Nausea and Vomiting Induced by High-Dose Chemotherapy in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Fosaprepitant, Tropisetron, Olanzapine, Dexamethasone
- Keywords
- Delayed vomiting, Multiple Myeloma, Fosaprepitant, Olanzapine, Tropisetron
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosaprepitantDrug
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
FosaprepitantDrug
150mg, intravenously 30 minutes before chemotherapy on day -3
TropisetronDrug
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
OlanzapineDrug
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
DexamethasoneDrug
6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0
| Study group | Role | What they receive |
|---|---|---|
| FTO regimen | Experimental | Fosaprepitant, Tropisetron and Olanzapine. Receives: Drug: Fosaprepitant; Drug: Tropisetron; Drug: Olanzapine |
| FTD regimen | Active comparator | Fosaprepitant, Tropisetron and Dexamethasone. Receives: Drug: Fosaprepitant; Drug: Tropisetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 to 240 hours after chemotherapy
Secondary outcomes (5)
Major Response (MR)
No vomiting with severe nausea (scoring 8-10 on the MASCC Antiemesis Tool), and no rescue medication use.
Measured: 0-240 hours after chemotherapy
Clinical Benefit Response (CBR)
CR+MR.
Measured: 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.
Measured: 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.
Measured: 0-240 hours after chemotherapy
Toxic Side Effects
Toxicity and adverse reaction assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 0-240 hours after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Sponsor type
- Other government
- Collaborators
- Zhejiang University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Jinhua Central Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital, Jinhua People's Hospital, Zhejiang Provincial Tongde Hospital, First Affiliated Hospital of Wenzhou Medical University, Dongyang People's Hospital, Taizhou Hospital
- Responsible party
- Sponsor
- Investigators
- Peipei Ye, Principal investigator, The Affiliated People's Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413809
- Sponsor's protocol ID
- 2025-097
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of Fosaprepitant Combined With Tropisetron and Multi-Day Olanzapine Versus Fosaprepitant Combined With Tropisetron and Dexamethasone for the Prevention of Delayed Nausea and Vomiting Induced by High-Dose Chemotherapy in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07413809
- Acronym / sponsor ID
- 2025-097
- Conditions
- Multiple Myeloma
- Keywords
- Delayed vomiting, Multiple Myeloma, Fosaprepitant, Olanzapine, Tropisetron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- The Affiliated People's Hospital of Ningbo UniversityOther government
- Collaborators
- Zhejiang University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Jinhua Central Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital, Jinhua People's Hospital, Zhejiang Provincial Tongde Hospital, First Affiliated Hospital of Wenzhou Medical University, Dongyang People's Hospital, Taizhou Hospital
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTO regimen | Experimental | Drug: Fosaprepitant, Drug: Tropisetron, Drug: OlanzapineFosaprepitant, Tropisetron and Olanzapine. |
| FTD regimen | Active comparator | Drug: Fosaprepitant, Drug: Tropisetron, Drug: DexamethasoneFosaprepitant, Tropisetron and Dexamethasone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation;
- Preconditioning regimen consists of melphalan at a dose of 200 mg/m²;
- ECOG performance status score of 0 to 2;
- Age >18 years and <65 years;
- Expected survival time >3 months;
Key exclusion criteria (5 listed)
- Presence of nausea or vomiting within 48 hours prior to enrollment, with prior use of antiemetic medications;
- Current use or use within the past month of CYP3A4 inducers, inhibitors, or substrate drugs;
- History of hypersensitivity to fosaprepitant or olanzapine;
- Serum creatinine clearance <60 mL/min;
- Inability to receive treatment and follow-up at the designated study site, or inability to comprehend, comply with the study protocol, or provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosaprepitant150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT | Drug | FTO regimen |
| Fosaprepitant150mg, intravenously 30 minutes before chemotherapy on day -3 | Drug | FTD regimen |
| Tropisetron5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2 | Drug | FTD regimen, FTO regimen |
| Olanzapine5mg, 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 | Drug | FTO regimen |
| Dexamethasone6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0 | Drug | FTD regimen |
Primary outcome
Complete Response (CR)
Time frame: 24 to 240 hours after chemotherapy
No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.
5 secondary outcomes
Major Response (MR)
Time frame: 0-240 hours after chemotherapy
Clinical Benefit Response (CBR)
Time frame: 0-240 hours after chemotherapy
Minor Response (MiR)
Time frame: 0-240 hours after chemotherapy
Treatment Failure (TF)
Time frame: 0-240 hours after chemotherapy
Toxic Side Effects
Time frame: 0-240 hours after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peipei Ye principal investigator
The Affiliated People's Hospital of Ningbo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosaprepitant, Tropisetron and Olanzapine in people with Multiple Myeloma, run by The Affiliated People's Hospital of Ningbo University at 1 site in China.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Peipei Ye (86-13685832706, 39612903@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) (time frame: 24 to 240 hours after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.