Preventing delayed nausea and vomiting after autologous transplant with olanzapine versus dexamethasone regimen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, randomized Phase 3 trial enrolled 92 patients with multiple myeloma scheduled for autologous hematopoietic stem cell transplantation after high-dose melphalan. Participants were randomized 1:1 to an experimental FTO regimen (fosaprepitant given every 72 hours, tropisetron, and nightly olanzapine) or a control FTD regimen (fosaprepitant, tropisetron, and dexamethasone). The primary endpoint was complete response (no emesis and no rescue medication) in the delayed phase (24–240 hours after chemotherapy), with acute and overall phases and additional response categories also compared. Safety and adverse events were monitored through day +8 post-transplant.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated People's Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Peipei Ye — The Affiliated People's Hospital of Ningbo University
• Study coordinator: Peipei Ye
• Email: 39612903@qq.com
• Phone: 86-13685832706

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma

  In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07907211

• Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

  This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT07851493

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.