Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients
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ClinicalTrials.gov Identifier: NCT01653106 |
Recruitment Status
:
Completed
First Posted
: July 30, 2012
Last Update Posted
: June 27, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma | Procedure: cryotherapy Other: questionnaire administration Other: pharmacological study | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 148 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 2012 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
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.
|
Procedure: cryotherapy
Receive shaved ice
Other: questionnaire administration
Participate in PROMS
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
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.
|
Procedure: cryotherapy
Receive shaved ice
Other: questionnaire administration
Participate in PROMS
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
- 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 ]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.
- 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 ]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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653106
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Craig Hofmeister, MD | Ohio State University |
Additional Information:
Responsible Party: | Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01653106 History of Changes |
Other Study ID Numbers: |
OSU-11055 NCI-2012-00459 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | July 30, 2012 Key Record Dates |
Last Update Posted: | June 27, 2017 |
Last Verified: | June 2017 |
Keywords provided by Craig Hofmeister, Ohio State University Comprehensive Cancer Center:
cryotherapy Melphalan Mucositis |
Additional relevant MeSH terms:
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
Immunoproliferative Disorders Immune System Diseases Melphalan Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |