Prevention of Delayed CINV after Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110061

Enrollment

Unknown

Registered

2025-09-29

Start date

2025-09-30

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

FTO group:FTO regimen: Fosaprepitant +Tropisetron+Olanzapine

FTD GROUP:FTO regimen: Fosaprepitant+Tropisetron+Dexamethasone

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation; 2. Preconditioning regimen consists of melphalan at a dose of 200 mg/m²; 3. ECOG score of 0–2; 4. Age >18 years and 3 months; 6. No intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting; 7. Ability to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of nausea or vomiting within 48 hours prior to enrollment, with prior use of antiemetic medications; 2. Current use or use within the past month of CYP3A4 inducers, inhibitors, or substrate drugs; 3. History of hypersensitivity to fosaprepitant or olanzapine; 4. Serum creatinine clearance <60 mL/min; 5. 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
Comparison of CR rates between FTO and FTD for delayed CINV after high-dose chemotherapy during HSCT.;	—

Secondary

Measure	Time frame
Observe and compare the Major Response (MR) of the FTO regimen versus the FTD regimen during the acute, delayed, and overall phases.;minor response (MiR),;clinical benefit response (CBR);Compare the CR rates of the FTO vs. FTD regimens in the acute (pre-chemotherapy to 24h post-chemotherapy) and overall (pre-chemotherapy to 240h post-chemotherapy) phases.;treatment failure (TF);the toxic side effects of the FTO and FTD regimens were observed and compared.;	—

Measure

Time frame

Observe and compare the Major Response (MR) of the FTO regimen versus the FTD regimen during the acute, delayed, and overall phases.;minor response (MiR),;clinical benefit response (CBR);Compare the CR rates of the FTO vs. FTD regimens in the acute (pre-chemotherapy to 24h post-chemotherapy) and overall (pre-chemotherapy to 240h post-chemotherapy) phases.;treatment failure (TF);the toxic side effects of the FTO and FTD regimens were observed and compared.;

—

Countries

China

Contacts

Public ContactLu Ying

The affiliated people's hospital of Ningbo University

814871416@qq.com+86 13486090834

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026