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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Description:

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.

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Craig Hofmeister, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-11055

NCT ID:

NCT01653106

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • cryotherapy
  • Melphalan
  • Mucositis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210