Plasma Cell Myeloma
Conditions
Brief summary
Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available. Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system. 100 participants will be enrolled in this study at Emory University.
Detailed description
PRIMARY OBJECTIVE: I. Assessing the quality and quantity of bone marrow core biopsies. SECONDARY OBJECTIVES: I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires. II. Timing of the actual procedure. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo bone marrow biopsy using the power drill. ARM II: Patients undergo bone marrow biopsy using the traditional Jamshidi needle. All patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. After completion of study treatment, patients are followed up periodically.
Interventions
DEVICEPower drill
Undergo bone marrow biopsy using power drill
DEVICEJamshidi needle
Undergo bone marrow biopsy using Jamshidi needle
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients with existing plasma cell disorders and no history of psychiatric disorders who can receive conscious sedation are eligible to participate in the trial
Exclusion criteria
* Pregnant women are excluded from participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist | At the time of biopsy | Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | At the time of, 30 minutes, 1, 3, and 7 days after biopsy | The VAS (visual analogue scale) for pain is on a 10 point scale. Pain is studied with chi-square, Mann Whitney U test, or Fisher's exact test. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain. |
| Time Taken by the Procedure Measured in Seconds Using a Stopwatch | At the time of biopsy | Staff members will use a stopwatch from the beginning to the completion of the procedure (skin to skin). Time taken for procedure is studied with mean, median, range, and standard deviation and compared by two-sample t-test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Biopsy Using Power Drill) Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
Power drill: Undergo bone marrow biopsy using power drill | 50 |
| Arm II (Biopsy Using Jamshidi Needle) Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Arm I (Biopsy Using Power Drill) | Arm II (Biopsy Using Jamshidi Needle) | Total |
|---|---|---|---|
| Age, Continuous | 65.5 years | 63 years | 64.25 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 49 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Prior Bone Marrow Aspiration & Biopsies (BMA&B) within the last 2 years | 50 Participants | 50 Participants | 100 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 20 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 30 Participants | 66 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Time frame: At the time of biopsy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Biopsy Using Power Drill) | Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist | 14 Millimeters |
| Arm II (Biopsy Using Jamshidi Needle) | Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist | 9.5 Millimeters |
Secondary
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
The VAS (visual analogue scale) for pain is on a 10 point scale. Pain is studied with chi-square, Mann Whitney U test, or Fisher's exact test. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain.
Time frame: At the time of, 30 minutes, 1, 3, and 7 days after biopsy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm I (Biopsy Using Power Drill) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 3 days after biopsy | .89 score on a scale |
| Arm I (Biopsy Using Power Drill) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 30 minutes | .66 score on a scale |
| Arm I (Biopsy Using Power Drill) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 7 days after biopsy | .18 score on a scale |
| Arm I (Biopsy Using Power Drill) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 1 day after biopsy | 1.62 score on a scale |
| Arm II (Biopsy Using Jamshidi Needle) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 7 days after biopsy | .26 score on a scale |
| Arm II (Biopsy Using Jamshidi Needle) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 30 minutes | .84 score on a scale |
| Arm II (Biopsy Using Jamshidi Needle) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 3 days after biopsy | .63 score on a scale |
| Arm II (Biopsy Using Jamshidi Needle) | Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire | 1 day after biopsy | 1.62 score on a scale |
Secondary
Time Taken by the Procedure Measured in Seconds Using a Stopwatch
Staff members will use a stopwatch from the beginning to the completion of the procedure (skin to skin). Time taken for procedure is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Time frame: At the time of biopsy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Biopsy Using Power Drill) | Time Taken by the Procedure Measured in Seconds Using a Stopwatch | 7 Seconds |
| Arm II (Biopsy Using Jamshidi Needle) | Time Taken by the Procedure Measured in Seconds Using a Stopwatch | 10.5 Seconds |