Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAugusta University

About this trial

Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea/vomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea/vomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Receipt of high-dose melphalan 140-200 mg/m2

Autologous stem cell transplantation recipient

Disqualifiers

Allergy to olanzapine

Documented nausea or vomiting within 24 hours prior to enrollment

Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy

Chronic alcoholism

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olanzapine

    Drug

    Subjects will be randomized to either olanzapine 2.5 mg or 5 mg

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: Olanzapine 2.5 mgExperimental treatment 1 intervention
Group B: Olanzapine 5 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete Response

The primary objective is to compare the percentage of patients achieving chemotherapy-induced nausea and vomiting (CINV) complete response (CR), where CR is defined as no emesis and no more than mild nausea (\</=1 score on a 4-point categorical scale \[0 = none, 1 = mild, 2 = moderate, and 3 = severe\]) during the overall assessment period (defined as the day of chemotherapy through 5 days after chemotherapy).

Time frame
From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

Secondary outcomes

1

Complete Protection

Complete protection (CP) defined as no emesis, no more than mild nausea, and no use of breakthrough antiemetic agents

Time frame
From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
2

Incidence of patients with no more than minimal sedation

Time frame
From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
3

Incidence of patients with no more than minimal nausea

Time frame
From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
4

Number of emetic episodes

Time frame
From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)

Other outcomes

Sponsors and contacts

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