Multiple MyelomaPhase 3FONDO-LOWNCT06588413
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
A Phase 3 study testing Olanzapine in people with Multiple Myeloma and Autologous Stem Cell Transplantation, run by Augusta University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Autologous Stem Cell Transplantation
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2024to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receipt of high-dose melphalan 140-200 mg/m2
- Autologous stem cell transplantation recipient
Who cannot join
- 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
- Pregnant
- Decline or unable to 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.
United States1 site, 1 recruiting
- Recruiting
Wellstar MCG
Augusta, Georgia, 30912
Amber Clemmons, PharmD, 706-721-6493, aclemmons@augusta.edu
About this study
Official title: Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study
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.
Read the detailed description
This study is a randomized, double-blinded trial comparing olanzapine 2.5 mg vs 5 mg in combination with standard triplet antiemetic prophylaxis in patients with multiple myeloma who are receiving high-dose melphalan conditioning chemotherapy before autologous stem cell transplantation to determine chemotherapy-induced nausea and vomiting (CINV) and sedation outcomes.
- Being tested
- Olanzapine
- Keywords
- CINV, Nausea, Olanzapine, Melphalan, autologous transplant
- Medical subject headings
- Multiple Myeloma, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine 2.5 mg | Experimental | Olanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after Receives: Drug: Olanzapine |
| Olanzapine 5 mg | Active comparator | Olanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Secondary outcomes (5)
Complete Protection
Complete protection (CP) defined as no emesis, no more than mild nausea, and no use of breakthrough antiemetic agents
Measured: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Incidence of patients with no more than minimal sedation
Measured: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Incidence of patients with no more than minimal nausea
Measured: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Number of emetic episodes
Measured: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Number of breakthrough antiemetic doses
Measured: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Clemmons, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588413
- Sponsor's protocol ID
- 2216424
- Acronym
- FONDO-LOW
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bajpai J, Kapu V, Rath S, Kumar S, Sekar A, Patil P, Siddiqui A, Anne S, Pawar A, Srinivas S, Bhargava P, Gulia S, Noronha V, Joshi A, Prabhash K, Banavali S, Sarin R, Badwe R, Gupta S. Low-dose versus standard-dose olanzapine with triple antiemetic therapy for prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with solid tumours: a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2024 Feb;25(2):246-254. doi: 10.1016/S1470-2045(23)00628-9. Epub 2024 Jan 12.
PubMed 38224701Clemmons AB, Orr J, Andrick B, Gandhi A, Sportes C, DeRemer D. Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial. Biol Blood Marrow Transplant. 2018 Oct;24(10):2065-2071. doi: 10.1016/j.bbmt.2018.06.005. Epub 2018 Jun 13.
PubMed 29906570
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study
- ClinicalTrials.gov ID
- NCT06588413
- Acronym / sponsor ID
- FONDO-LOW / 2216424
- Keywords
- CINV, Nausea, Olanzapine, Melphalan, autologous transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
Detailed description
This study is a randomized, double-blinded trial comparing olanzapine 2.5 mg vs 5 mg in combination with standard triplet antiemetic prophylaxis in patients with multiple myeloma who are receiving high-dose melphalan conditioning chemotherapy before autologous stem cell transplantation to determine chemotherapy-induced nausea and vomiting (CINV) and sedation outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine 2.5 mg | Experimental | Drug: OlanzapineOlanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after |
| Olanzapine 5 mg | Active comparator | Drug: OlanzapineOlanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receipt of high-dose melphalan 140-200 mg/m2
- Autologous stem cell transplantation recipient
Key exclusion criteria (6 listed)
- 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
- Pregnant
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 |
|---|---|---|
| OlanzapineAlso: ZyprexaSubjects will be randomized to either olanzapine 2.5 mg or 5 mg | Drug | Olanzapine 2.5 mg, Olanzapine 5 mg |
Primary outcome
Complete Response
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
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).
5 secondary outcomes
Complete Protection
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Incidence of patients with no more than minimal sedation
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Incidence of patients with no more than minimal nausea
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Number of emetic episodes
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
Number of breakthrough antiemetic doses
Time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)
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 22 Nov 2024.
- Background: PubMed 38224701Bajpai J, Kapu V, Rath S, Kumar S, Sekar A, Patil P, Siddiqui A, Anne S, Pawar A, Srinivas S, Bhargava P, Gulia S, Noronha V, Joshi A, Prabhash K, Banavali S, Sarin R, Badwe R, Gupta S. Low-dose versus standard-dose olanzapine with triple antiemetic therapy for prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with solid tumours: a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2024 Feb;25(2):246-254. doi: 10.1016/S1470-2045(23)00628-9. Epub 2024 Jan 12.
- Background: PubMed 29906570Clemmons AB, Orr J, Andrick B, Gandhi A, Sportes C, DeRemer D. Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial. Biol Blood Marrow Transplant. 2018 Oct;24(10):2065-2071. doi: 10.1016/j.bbmt.2018.06.005. Epub 2018 Jun 13.
- 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.
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 Olanzapine in people with Multiple Myeloma and Autologous Stem Cell Transplantation, run by Augusta University at 1 site in United States.
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 2 inclusion and 6 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 22 Nov 2024. 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 United States. 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 Amber Clemmons, PharmD, BCOP, FHOPA (706-721-6493, aclemmons@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588413, which also lists 2 linked publications.
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 22 Nov 2024.