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A Double-Blind Phase 2 Study to Assess the Safety and Efficacy of Aloxi (Palonosetron HCl) for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving High-Dose Melphalan as Conditioning Chemotherapy for Stem Cell Transplantation

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Double-Blind Phase 2 Study to Assess the Safety and Efficacy of Aloxi (Palonosetron HCl) for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving High-Dose Melphalan as Conditioning Chemotherapy for Stem Cell Transplantation

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.

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:

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,

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Principal Investigator

Michael Schuster, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cornell Medical Center, Division of Hematology-Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

December 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Stem Cell Transplantation
  • CINV
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



MD Anderson Cancer CenterHouston, Texas  77030-4096
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Oregon Health & Science UniversityPortland, Oregon  97201
Cornell Medical CenterNew York, New York  10021
Texas Transplant InstituteSan Antonio, Texas  78229
Wake Forest Medical CenterWinston-Salem, North Carolina  27157
Fox Chase-TemplePhiladelphia, Pennsylvania  19111
Baylor University Blood and Marrow TransplantationDallas, Texas  75246
Fairfax-Northern Virginia Hematology-Oncology PCFairfax, Virginia  22031