Multiple MyelomaNCT01382615
Protocol to Obtain Blood and Bone Marrow Samples for Myeloma Research
An observational study of Multiple Myeloma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center
Who may be able to join
- Participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient.
Who cannot join
- Patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Evaluation of Immune Parameters and Function in Multiple Myeloma Patients and Healthy Individuals' Blood and Marrow Samples
The purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma.
Read the detailed description
The blood and bone marrow samples will be used in the laboratory to perform focused studies on multiple myeloma.
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient. | |
| Patients with multiple myeloma | Patients undergoing routine blood draw and bone marrow aspirates as part of their ongoing follow-up care for myeloma at the Norris Cotton Cancer Center of DHMC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer cell response to molecular testing of killing cell parts.
This myeloma specific killing may help identify mechanisms, in vitro, of killing myeloma cells for the future use in clinical trials.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Unable to fill cohort
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Meehan, Dartmouth-Hitchcock Medical Center
- Investigators
- Kenneth Meehan, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382615
- Sponsor's protocol ID
- D1029
- Status last verified
- May 2016
- First submitted
- 12 Apr 2010
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Parameters and Function in Multiple Myeloma Patients and Healthy Individuals' Blood and Marrow Samples
- ClinicalTrials.gov ID
- NCT01382615
- Acronym / sponsor ID
- D1029
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to fill cohort
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma.
Detailed description
The blood and bone marrow samples will be used in the laboratory to perform focused studies on multiple myeloma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient. |
| Patients with multiple myeloma | – | –Patients undergoing routine blood draw and bone marrow aspirates as part of their ongoing follow-up care for myeloma at the Norris Cotton Cancer Center of DHMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center
Key inclusion criteria (1 listed)
- Participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient.
Key exclusion criteria (1 listed)
- Patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer cell response to molecular testing of killing cell parts.
Time frame: 2 Years
This myeloma specific killing may help identify mechanisms, in vitro, of killing myeloma cells for the future use in clinical trials.
Results and safety
The study was stopped early (reason given: Unable to fill cohort). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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.
Kenneth Meehan, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Dartmouth-Hitchcock Medical Center 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: stopped early, as of the sponsor's last update on 25 Apr 2018. 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?
The study was stopped early (reason given: Unable to fill cohort). Results are not available in the source record.
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?
Cancer cell response to molecular testing of killing cell parts. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2018.