Multiple MyelomaNCT02682667
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
An observational study of Multiple Myeloma and Lymphoma, Non-Hodgkin, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Leukemia-Lymphoma, Adult T-Cell
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2016to 1 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be any person over the age of 18 with a diagnosis of cancer or a premalignant disease. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.
Who may be able to join
- Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition
- Age >=18 years of age
- ECOG performance status of 0-3.
- 5. Ability and willingness of subject to provide informed consent
- Additional inclusion criteria pertinent only for participants undergoing apheresis
- Hemoglobin >= 8 mg/dL and platelet count > 75 K/microL
- Weight >= 48 kg
- Central line in place or adequate venous access
Who cannot join
- Active concomitant medical or psychological illnesses that may increase the risk to the subject.
- Inability to provide informed consent
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.
Read more
Objective:
To better understand the biology of malignancies and why certain cancers respond differently to treatment.
Eligibility:
Adults at least 18 years old with cancer or a pre-cancerous condition.
Design:
Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.
Participants will send tissue blocks or slides from their original tumor biopsy.
At least once, participants will have a medical history, physical exam, and blood and urine tests.
Participants may have the following tests. They may have them more than once:
Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.
Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.
Piece of cancer tissue taken by a needle and syringe.
Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.
A small piece of skin removed.
Participants will be contacted by phone once a year to find out how they are doing.
Read the detailed description
Background:
-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.
Objectives:
- To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.
- To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.
- To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.
Eligibility:
-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.
Design:
- Up to 500 subjects will be enrolled.
- Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.
- No investigational or experimental therapy will be given as part of this protocol.
- Re-enrollment will be allowed for a small number of participants.
- Conditions
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Leukemia-Lymphoma, Adult T-Cell, Hodgkin Disease, Non-Small Cell Lung Cancer
- Keywords
- Apheresis Products, Immunological, Diverse Malignan, Premalignant, Protein, Natural History
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Leukemia-Lymphoma, Adult T-Cell, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Precancerous Conditions
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 |
|---|---|---|
| 1/Cohort 1 | Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample Acquisition
Biospecimen collection for study and understanding of disease.
Measured: Ongoing
Secondary outcomes (1)
Associations between clinical parameters, biospecimen characteristics and patient demographics
Correlation of these characteristics with disease.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start11 Apr 2016
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2032 (estimated)
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 National Cancer Institute (NCI)The 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott M Norberg, D.O., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682667
- Sponsor's protocol ID
- 160061
- Other IDs
- 16-C-0061
- Status last verified
- 13 Oct 2026
- First submitted
- 10 Feb 2016
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
- ClinicalTrials.gov ID
- NCT02682667
- Acronym / sponsor ID
- 160061
- Conditions
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Leukemia-Lymphoma, Adult T-Cell, Hodgkin Disease, Non-Small Cell Lung Cancer
- Keywords
- Apheresis Products, Immunological, Diverse Malignan, Premalignant, Protein, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 15 Feb 2016 (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.
Background:
Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.
Objective:
To better understand the biology of malignancies and why certain cancers respond differently to treatment.
Eligibility:
Adults at least 18 years old with cancer or a pre-cancerous condition.
Design:
Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.
Participants will send tissue blocks or slides from their original tumor biopsy.
At least once, participants will have a medical history, physical exam, and blood and urine tests.
Participants may have the following tests. They may have them more than once:
Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.
Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.
Piece of cancer tissue taken by a needle and syringe.
Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.
A small piece of skin removed.
Participants will be contacted by phone once a year to find out how they are doing.
Detailed description
Background:
-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.
Objectives:
- To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.
- To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.
- To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.
Eligibility:
-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.
Design:
- Up to 500 subjects will be enrolled.
- Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.
- No investigational or experimental therapy will be given as part of this protocol.
- Re-enrollment will be allowed for a small number of participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Cohort 1 | – | –Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be any person over the age of 18 with a diagnosis of cancer or a premalignant disease. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.
Key inclusion criteria (8 listed)
- 5. Ability and willingness of subject to provide informed consent
- Additional inclusion criteria pertinent only for participants undergoing apheresis
- Hemoglobin >= 8 mg/dL and platelet count > 75 K/microL
- Weight >= 48 kg
- Central line in place or adequate venous access
Key exclusion criteria (3 listed)
- Active concomitant medical or psychological illnesses that may increase the risk to the subject.
- Inability to provide informed consent
- Pregnant or breastfeeding women
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
Sample Acquisition
Time frame: Ongoing
Biospecimen collection for study and understanding of disease.
1 secondary outcome
Associations between clinical parameters, biospecimen characteristics and patient demographics
Time frame: Ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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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.
Scott M Norberg, D.O. principal investigator
National Cancer Institute (NCI)
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 and Lymphoma, Non-Hodgkin, run by National Cancer Institute (NCI) 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott M Norberg, D.O. ((301) 275-9668, scott.norberg@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample Acquisition (time frame: Ongoing). 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 26 Oct 2026.