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Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01653106
First received: July 26, 2012
Last updated: May 12, 2014
Last verified: May 2014

July 26, 2012
May 12, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
Incidence of severe (Grade 3 or 4) mucositis achieved between two different cryotherapy regimens during inpatient hospitalization based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
A Cochran-Mantel-Haenszel chi-square test will be used to compare the proportion of patients who develop severe mucositis between those treated with 120-minute vs. 360-minute cryotherapy. Logistic regression modeling will also be used with incidence of severe mucositis as the dependent variable and assess various factors in addition to treatment arm on this incidence.
Same as current
Complete list of historical versions of study NCT01653106 on ClinicalTrials.gov Archive Site
Melphalan pharmacokinetic model including apparent volume of the central compartment (Vc), elimination rate of constant (Ke), half-life (t1/2), systemic clearance (CLs), and AUC. [ Time Frame: Pre-dose, within 5 minutes prior to completion of infusion, at 5, 15, 30, 45, and 60 minutes, and 3 and 6 hours post end of infusion ] [ Designated as safety issue: No ]
All pharmacokinetic results will be summarized using appropriate descriptive statistics. A nonlinear mixed effects approach will be used for modeling melphalan pharmacokinetics, identifying significant covariates, and relating these to mucositis.
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Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients
A Randomized Study to Compare the Effect of Short- and Long-Term Schedules of Cryotherapy on the Incidence and Severity of Mucositis in High-Dose Melphalan

The purpose of this study is to compare the effect of short-term (2 hours/120 minutes) and long-term (6 hours/360 minutes) schedules of crushed ice therapy (cryotherapy). Patients that receive high dose melphalan for bone marrow transplantation commonly develop significant mouth pain and sores (oral mucositis) unless cryotherapy is utilized. The goal of this study is to scientifically determine (using randomization and a larger sample size) if a short-term schedule is as effective as the standard long-term schedule in preventing, or minimizing the symptoms involved with oral mucositis. The study is also trying to determine the best dose of melphalan and how patient's body breaks down melphalan and will obtain blood through central venous catheter to measure the amount of melphalan in patient's blood at specific times after the melphalan is infused

PRIMARY OBJECTIVES:

I. To measure the maximum inpatient mucositis grade after 120- vs. 360-minutes standardized cryotherapy regimens in patients with multiple myeloma undergoing autologous hematopoietic stem cell transplantation at Ohio State Medical Center.

SECONDARY OBJECTIVES:

I. To develop a pharmacokinetic model predicting variability in unbound serum melphalan area under the concentration-time curve (AUC).

II. To compare the neutropenic fever and bacteremia incidence after 120- vs. 360-minute cryotherapy regimens.

III. To compare patient-reported mucositis-related symptoms up until discharge utilizing the Patient-Reported Oral Mucositis Symptoms Scale (PROMS) after 120- vs 360-minute cryotherapy regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 120 minutes.

ARM II: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 360 minutes.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Procedure: cryotherapy
    Receive shaved ice
  • Other: questionnaire administration
    Participate in PROMS
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Experimental: Arm I (cryotherapy 120 minutes)
    Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 120 minutes.
    Interventions:
    • Procedure: cryotherapy
    • Other: questionnaire administration
    • Other: pharmacological study
  • Active Comparator: Arm II (cryotherapy 360 minutes)
    Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 360 minutes.
    Interventions:
    • Procedure: cryotherapy
    • Other: questionnaire administration
    • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
Not Provided
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be diagnosed with multiple myeloma be admitted for autologous stem cell transplantation
  • Age > 18 years
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial

Exclusion Criteria:

  • Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01653106
OSU-11055, NCI-2012-00459
Yes
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Craig Hofmeister, MD Ohio State University
Ohio State University Comprehensive Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP