CClinicalTrials.gg
CompletedNCT00306735Updated Dec 5, 2016

Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.

A Phase 2 interventional study of Palonosetron in Multiple Myeloma, sponsored by Eisai Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by Eisai Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.

Read the detailed description

A number of multiple-day chemotherapy regimens involving moderately or highly emetogenic agents are used for the treatment of cancers. Further, patients undergoing high-dose conditioning regimens in combination with bone marrow or stem cell transplants remain poorly controlled in terms of CINV. Patients treated with these regimens are at risk for developing CINV with each treatment as well as in the delayed setting.

Palonosetron to date, has been studied against single-day moderately and highly emetogenic chemotherapy regimens. It is of interest, therefore, to explore the safety and efficacy of palonosetron when administered during a multiple-day chemotherapy regimen. For this purpose, a population receiving melphalan (100 mg/m\^2) as a conditioning regimen before stem cell transplant for the treatment of multiple myeloma was selected.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Stem Cell Transplantation
  • CINV
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 75 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Provide written informed consent
  2. Age greater than or equal to 18 years
  3. Histologically confirmed multiple myeloma
  4. Karnofsky index greater than or equal to 50%
  5. Scheduled to receive a regimen containing melphalan at a dose of 100 mg/m\^2 on Study Days -2 and -1 followed by autologous stem cell transplant on Day 0
  6. Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
  7. Women of childbearing potential must use reliable contraceptive measures and have negative pregnancy tests at screening

Exclusion criteria

Exclusion Criteria:

  1. Inability or unwillingness to understand or to cooperate with the study procedures
  2. Received any investigational drugs within 30 days before study entry
  3. Received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on Study Day -2 or are scheduled to receive or anticipate use of any drug of this type (with the exception of palonosetron or dexamethasone as indicated for this study) during the trial, including the following:

    1. 5-HT3 receptor antagonists;
    2. Dopamine receptor antagonists (metoclopramide);
    3. Phenothiazine antiemetics (prochlorperazine, thiethylperazine and perphenazine);
    4. Atypical antipsychotic agents with Compazine-like activity (e.g. olanzapine, risperidone);
    5. Haloperidol, droperidol, tetrahydrocannabinol, or nabilone;
    6. Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), unless used as a preventative measure for chemotherapy toxicities. Topical or inhaled preparations are allowed; and,
    7. Any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either cause nausea or vomiting or used to treat nausea or vomiting.

    Note: with the exception of first-generation 5-HT3-receptor antagonists, above medication(s) may be used as rescue medication.

  4. Any vomiting, retching or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0, Grade 2-4 nausea in the 24 hours preceding chemotherapy;
  5. Ongoing vomiting for any organic etiology;
  6. Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in the protocol;
  7. Known contraindication to 5-HT3 receptor antagonists;
  8. Received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Palonosetron

    Drug: Palonosetron

Interventions

  • DrugPalonosetron
06

Study locations

10 sites
  • Indiana Blood and Marrow Transplantation
    Beech Grove, Indiana 46107, United States
  • Cornell Medical Center
    New York, New York 10021, United States
  • Wake Forest Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Fox Chase-Temple
    Philadelphia, Pennsylvania 19111, United States
  • Baylor University Blood and Marrow Transplantation
    Dallas, Texas 75246, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Texas Transplant Institute
    San Antonio, Texas 78229, United States
  • Fairfax-Northern Virginia Hematology-Oncology PC
    Fairfax, Virginia 22031, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00306735
Lead sponsor
Eisai Inc.
Collaborators
Helsinn Healthcare SA
First posted
Mar 24, 2006
Start date
Mar 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Dec 5, 2016

Study contacts

Michael Schuster, M.D.
principal investigator · Cornell Medical Center, Division of Hematology-Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion