Plasma Cell MyelomaNCT03078452

Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

A study testing Power drill and Jamshidi needle in people with Plasma Cell Myeloma, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Plasma Cell Myeloma
What is being tested?: Power drill and Jamshidi needle
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2017to 1 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnant women are excluded from participating in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Comparison of Quality of Bone Marrow Biopsy and Patient Convenience and Pain Control by a Battery Powered Drill Versus Conventional Methods in Patients With Plasma Cell Disorders

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.

Read the detailed description

PRIMARY OBJECTIVE:

Assessing the quality and quantity of bone marrow core biopsies.

SECONDARY OBJECTIVES:

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.

Conditions: Plasma Cell Myeloma
Being tested: Power drill, Jamshidi needle
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Power drillDevice
Undergo bone marrow biopsy using power drill
Jamshidi needleDevice
Undergo bone marrow biopsy using Jamshidi needle

Study groups in NCT03078452
Study group	Role	What they receive
Arm I (biopsy using power drill)	Experimental	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. Receives: Device: Power drill
Arm II (biopsy using Jamshidi needle)	Active comparator	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. Receives: Device: Jamshidi needle

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At the time of biopsy

Secondary outcomes (2)

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.
Measured: At the time of, 30 minutes, 1, 3, and 7 days after biopsy
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.
Measured: At the time of biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20171 Dec 2023

First posted13 Mar 2017
Study start14 Feb 2017
Primary completion1 Dec 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03078452
Sponsor's protocol ID: IRB00075658
Other IDs: NCI-2017-00308, Winship2656-14, P30CA138292
Status last verified: Aug 2025
First submitted: 10 Mar 2017
Last updated: 8 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)

All Plasma Cell Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Quality of Bone Marrow Biopsy and Patient Convenience and Pain Control by a Battery Powered Drill Versus Conventional Methods in Patients With Plasma Cell Disorders
ClinicalTrials.gov ID: NCT03078452
Acronym / sponsor ID: IRB00075658
Conditions: Plasma Cell Myeloma
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 14 Feb 2017 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 13 Mar 2017 (actual)
Results: Posted 8 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

100 participants will be enrolled in this study at Emory University.

Detailed description

PRIMARY OBJECTIVE:

Assessing the quality and quantity of bone marrow core biopsies.

SECONDARY OBJECTIVES:

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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (biopsy using power drill)	Experimental	Device: Power drillPatients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
Arm II (biopsy using Jamshidi needle)	Active comparator	Device: Jamshidi needlePatients 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Pregnant women are excluded from participating in this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Power drillUndergo bone marrow biopsy using power drill	Device	Arm I (biopsy using power drill)
Jamshidi needleUndergo bone marrow biopsy using Jamshidi needle	Device	Arm II (biopsy using Jamshidi needle)

Primary outcome

Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
Time frame: 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.

2 secondary outcomes

Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
Time frame: At the time of, 30 minutes, 1, 3, and 7 days after biopsy
Time Taken by the Procedure Measured in Seconds Using a Stopwatch
Time frame: At the time of biopsy

Results and safety

Results posted to the registry on 8 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Biopsy Using Power Drill)	50	50
Arm II (Biopsy Using Jamshidi Needle)	50	50

Primary outcome: Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist

Time frame: At the time of biopsy. Mean (95% Confidence Interval). Unit: Millimeters

Measure	Arm I (Biopsy Using Power Drill) n = 50	Arm II (Biopsy Using Jamshidi Needle) n = 50
Value	14 (5 to 30)	9.5 (3 to 23)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected for each patient through day +7 after enrollment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Biopsy Using Power Drill)	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Arm II (Biopsy Using Jamshidi Needle)	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Plasma Cell Myeloma

RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ajay Nooka, MD, MPH principal investigator

Emory University/Winship Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Power drill and Jamshidi needle in people with Plasma Cell Myeloma, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist (time frame: At the time of biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03078452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.