Multiple Myeloma
Conditions
Keywords
Delayed vomiting, Multiple Myeloma, Fosaprepitant, Olanzapine, Tropisetron
Brief 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). 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.
Interventions
DRUGFosaprepitant
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
DRUGTropisetron
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
DRUGOlanzapine
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
DRUGDexamethasone
6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0
Sponsors
The Affiliated People's Hospital of Ningbo University
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Response (MR) | 0-240 hours after chemotherapy | No vomiting with severe nausea (scoring 8-10 on the MASCC Antiemesis Tool), and no rescue medication use. |
| Clinical Benefit Response (CBR) | 0-240 hours after chemotherapy | CR+MR. |
| Minor Response (MiR) | 0-240 hours after chemotherapy | 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. |
| Treatment Failure (TF) | 0-240 hours after chemotherapy | 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. |
| Toxic Side Effects | 0-240 hours after chemotherapy | Toxicity and adverse reaction assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
Countries
China
Contacts
CONTACTPeipei Ye
CONTACTYing Lu
PRINCIPAL_INVESTIGATORPeipei Ye
The Affiliated People's Hospital of Ningbo University
Outcome results
None listed