Multiple MyelomaPhase 2NCT01248455
A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma
A Phase 2 study testing (Anti-KIR) in people with Multiple Myeloma and Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Myeloma, Smoldering Multiple Myeloma
- What is being tested?
- (Anti-KIR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2010to Apr 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of smoldering multiple myeloma (SMM) will be made in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group. These criteria include:
- Serum M-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal to 10 percent
- Absence of anemia: Hemoglobin greater than or equal to 10 g/dl
- Absence of renal failure: calculated creatinine clearance (according to modification of diet in renal disease (MDRD)) greater than or equal to 40 ml/min (or alternatively based on standard creatinine level criteria of 2 mg/dl)
- Absence of hypercalcemia: Calcium less than or equal to 10.5 mg/dl
- Absence of lytic bone lesion (skeletal survey)
Show all 11Show fewer
- The diagnoses will be confirmed by serum/urine protein electrophoresis, immunofixation and light-chain assays; as well as immunohistochemical analyses of the bone marrow biopsy.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Male or female patient who accepts and is able to use recognized effective contraception (oral contraceptives, intrauterine contraceptive device (IUCD), barrier method of contraception in conjunction with spermicidal jelly) through the study and for four months following the final dose of study drug when relevant.
- The patient must be competent to sign an informed consent form.
Who cannot join
- Patients with a diagnosis of multiple myeloma (MM) or a clinical suspicion of an ongoing progression into full-blown MM
- Patients without measurable disease defined as serum monoclonal protein (M-protein) less than 1 g/dL.
- Previous treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, immunomodulatory drugs (IMiDs), or proteasome inhibitors).
- Use of any investigational agent within the last 3 months.
- Clinical laboratory values at screening:
- Platelet levels less than 75 times 10^9/L
Show all 28Show fewer
- Absolute neutrophil count (ANC) levels less than 1 times 10^9/L
- Bilirubin levels greater than 1.5 upper limit of normal (ULN) ; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3.0 ULN (grade 1 National Cancer Institute (NCI))
- Primary or associated amyloidosis
- Known abnormal cardiac status with any of the following:
- New York Heart Association (NYHA) stage III or IV congestive heart failure
- Myocardial infarction within the previous 6 months
- Symptomatic and/or treatment-refractory cardiac arrhythmia. Patients with controlled or asymptomatic arrhythmia are not excluded from this study.
- Current active infectious disease or positive serology for:
- Human Immunodeficiency Virus (HIV)
- Hepatitis C Virus (HCV)
- Hepatitis B Surface Antigen
- Severe type of autoimmune disease defined as:
- One which currently requires or previously required long-term systemic immunosuppressive or immunomodulatory therapy (including corticosteroids, administered by systemic route)
- And/or it has a substantial probability to cause an irreversible injury to any tissue (e.g. Hashimoto thyroiditis).
- And/or it is recent or unstable, or has a substantial risk to progress and cause severe complications (e.g. Graves disease)
- Enrollment of other non severe types of auto-immunes disease requiring topical therapy, or non-steroidal inflammatory drugs (NSAIDS) can be considered on a case by case basis by the Principal Investigator.
- History of a lymphoproliferative malignancy.
- History of other malignancy (apart from basal cell carcinoma of the skin or in situ cervical carcinoma) except if the patient has been free of symptoms and without active therapy during at least the previous 5 years.
- Serious concurrent uncontrolled medical disorder.
- History of allograft or solid organ transplantation.
- Any psychological or familial condition potentially interfering with compliance with the study protocol and follow-up schedule.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial of IPH2101 (Anti-KIR) in Smoldering Multiple Myeloma (SMM)
Background:
- Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. People with smoldering multiple myeloma have abnormal blood test results that show a high level of monoclonal protein (M-protein) in the blood and of plasma cells in the bone marrow. There are currently no known effective treatments to prevent smoldering multiple myeloma from developing into multiple myeloma, and there are no known tests for determining whether an individual with smoldering multiple myeloma will develop multiple myeloma.
- Certain cells in the immune system, known as natural killer (NK) cells, are active against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells. Researchers are interested in determining whether anti-KIR can be given to individuals with smoldering multiple myeloma to improve their abnormal blood test results.
Read more
Objectives:
- To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test results related to smoldering multiple myeloma.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with smoldering multiple myeloma.
Design:
- Participants will be screened with a physical examination and medical history, and will provide baseline blood, urine, and bone marrow samples before beginning the study drug.
- Participants will receive anti-KIR intravenously for 1 hour, and will be closely monitored for 24 hours after receiving the first dose. If there are no serious side effects, participants will receive five additional anti-KIR doses, one every other month, for a total of six treatment cycles.
- Participants will have monthly visits to provide additional blood and urine samples, and may have additional bone marrow biopsies as directed by the study researchers.
- Participants will have followup visits every 3 to 6 months for up to 5 years after receiving anti-KIR treatment.
Read the detailed description
Background:
- Multiple myeloma (MM) is an incurable plasma cell neoplasm with a median survival of 3-4 years.
- Smoldering multiple myeloma (SMM) is a premalignant plasma cell disorder characterized by monoclonal protein greater than or equal to 3 g/dL or bone marrow plasma cells greater than or equal to 10 percent in the absence of myeloma-related tissue impairment with 51 percent progression to MM at 5 years.
- Current recommendations do not endorse treatment of SMM with chemotherapy.
- Transplanted Natural Killer (NK) Cells have anti-myeloma activity.
- Anti-KIR (IPH2101) is a monoclonal antibody that facilitates NK cell mediated killing of myeloma cells by blocking inhibitory receptors (KIR) on NK cells.
Objectives:
- To assess the response rate of anti-KIR(IPH2101) in patients with SMM
- To evaluate the toxicity of anti-KIR(IPH2101) in patients with SMM
- To evaluate the pharmacokinetic parameters and biological activity of anti-KIR (IPH2101)
Eligibility:
- A confirmed diagnosis of SMM
- Age greater than or equal to 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status in the range of 0-1.
- Without serious co-morbidity that would interfere with receipt of anti-KIR(IPH2101)
Design:
- Single-arm Phase II trial of anti-KIR(IPH2101) for patients with SMM.
- All patients will have initial evaluation and confirmation of diagnosis.
- Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles.
- Patients will have routine blood work with serum protein electrophoresis (SPEP) and immunofixation monthly.
- Pre- and post-treatment bone marrow biopsies will be obtained for confirmation of diagnosis and correlative studies.
- Patients may donate cellular products or tissues as appropriate for research purposes.
- Optimal two-stage phase II design will be employed, initially enrolling 9 patients. If 3 or more have a positive outcome, then a total of 21 patients will be enrolled in this study.
- Conditions
- Multiple Myeloma, Myeloma, Smoldering Multiple Myeloma
- Being tested
- (Anti-KIR)
- Keywords
- Monoclonal Antibody, NK Cell Mediated Killing, Response Rate, Pharmacokinetics, Biological Activity, Smoldering Multiple Myeloma, SMM
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Anti-KIR)Drug
Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| anti-KIR in Smoldering Multiple Myeloma Patients | Experimental | Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles Receives: Drug: (Anti-KIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR >25% and <50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium >2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin <10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.
Measured: 1 year
Secondary outcomes (1)
Count of Participants With Serious and Non-Serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Date treatment consent signed to date off study, approximately 3 years and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study start1 Nov 2010
- Primary completion1 May 2014
- Study completionApr 2015
Why it stopped: Lack of patients meeting the defined primary obj. (50% decline in M-protein).
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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Dickran Kazandjian, M.D., National Cancer Institute (NCI)
- Investigators
- Mark J Roschewski, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248455
- Sponsor's protocol ID
- 110024
- Other IDs
- 11-C-0024
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2010
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson KC, Kyle RA, Rajkumar SV, Stewart AK, Weber D, Richardson P; ASH/FDA Panel on Clinical Endpoints in Multiple Myeloma. Clinically relevant end points and new drug approvals for myeloma. Leukemia. 2008 Feb;22(2):231-9. doi: 10.1038/sj.leu.2405016. Epub 2007 Nov 1.
PubMed 17972944Kristinsson SY, Landgren O, Dickman PW, Derolf AR, Bjorkholm M. Patterns of survival in multiple myeloma: a population-based study of patients diagnosed in Sweden from 1973 to 2003. J Clin Oncol. 2007 May 20;25(15):1993-9. doi: 10.1200/JCO.2006.09.0100. Epub 2007 Apr 9.
PubMed 17420512Landgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, Dispenzieri A, Kumar S, Clark RJ, Baris D, Hoover R, Rajkumar SV. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009 May 28;113(22):5412-7. doi: 10.1182/blood-2008-12-194241. Epub 2009 Jan 29.
PubMed 19179464Korde N, Carlsten M, Lee MJ, Minter A, Tan E, Kwok M, Manasanch E, Bhutani M, Tageja N, Roschewski M, Zingone A, Costello R, Mulquin M, Zuchlinski D, Maric I, Calvo KR, Braylan R, Tembhare P, Yuan C, Stetler-Stevenson M, Trepel J, Childs R, Landgren O. A phase II trial of pan-KIR2D blockade with IPH2101 in smoldering multiple myeloma. Haematologica. 2014 Jun;99(6):e81-3. doi: 10.3324/haematol.2013.103085. Epub 2014 Mar 21. No abstract available.
PubMed 24658821
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of IPH2101 (Anti-KIR) in Smoldering Multiple Myeloma (SMM)
- ClinicalTrials.gov ID
- NCT01248455
- Acronym / sponsor ID
- 110024
- Conditions
- Multiple Myeloma, Myeloma, Smoldering Multiple Myeloma
- Keywords
- Monoclonal Antibody, NK Cell Mediated Killing, Response Rate, Pharmacokinetics, Biological Activity, Smoldering Multiple Myeloma, SMM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients meeting the defined primary obj. (50% decline in M-protein).
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. People with smoldering multiple myeloma have abnormal blood test results that show a high level of monoclonal protein (M-protein) in the blood and of plasma cells in the bone marrow. There are currently no known effective treatments to prevent smoldering multiple myeloma from developing into multiple myeloma, and there are no known tests for determining whether an individual with smoldering multiple myeloma will develop multiple myeloma.
- Certain cells in the immune system, known as natural killer (NK) cells, are active against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells. Researchers are interested in determining whether anti-KIR can be given to individuals with smoldering multiple myeloma to improve their abnormal blood test results.
Objectives:
- To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test results related to smoldering multiple myeloma.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with smoldering multiple myeloma.
Design:
- Participants will be screened with a physical examination and medical history, and will provide baseline blood, urine, and bone marrow samples before beginning the study drug.
- Participants will receive anti-KIR intravenously for 1 hour, and will be closely monitored for 24 hours after receiving the first dose. If there are no serious side effects, participants will receive five additional anti-KIR doses, one every other month, for a total of six treatment cycles.
- Participants will have monthly visits to provide additional blood and urine samples, and may have additional bone marrow biopsies as directed by the study researchers.
- Participants will have followup visits every 3 to 6 months for up to 5 years after receiving anti-KIR treatment.
Detailed description
Background:
- Multiple myeloma (MM) is an incurable plasma cell neoplasm with a median survival of 3-4 years.
- Smoldering multiple myeloma (SMM) is a premalignant plasma cell disorder characterized by monoclonal protein greater than or equal to 3 g/dL or bone marrow plasma cells greater than or equal to 10 percent in the absence of myeloma-related tissue impairment with 51 percent progression to MM at 5 years.
- Current recommendations do not endorse treatment of SMM with chemotherapy.
- Transplanted Natural Killer (NK) Cells have anti-myeloma activity.
- Anti-KIR (IPH2101) is a monoclonal antibody that facilitates NK cell mediated killing of myeloma cells by blocking inhibitory receptors (KIR) on NK cells.
Objectives:
- To assess the response rate of anti-KIR(IPH2101) in patients with SMM
- To evaluate the toxicity of anti-KIR(IPH2101) in patients with SMM
- To evaluate the pharmacokinetic parameters and biological activity of anti-KIR (IPH2101)
Eligibility:
- A confirmed diagnosis of SMM
- Age greater than or equal to 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status in the range of 0-1.
- Without serious co-morbidity that would interfere with receipt of anti-KIR(IPH2101)
Design:
- Single-arm Phase II trial of anti-KIR(IPH2101) for patients with SMM.
- All patients will have initial evaluation and confirmation of diagnosis.
- Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles.
- Patients will have routine blood work with serum protein electrophoresis (SPEP) and immunofixation monthly.
- Pre- and post-treatment bone marrow biopsies will be obtained for confirmation of diagnosis and correlative studies.
- Patients may donate cellular products or tissues as appropriate for research purposes.
- Optimal two-stage phase II design will be employed, initially enrolling 9 patients. If 3 or more have a positive outcome, then a total of 21 patients will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-KIR in Smoldering Multiple Myeloma Patients | Experimental | Drug: (Anti-KIR)Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of smoldering multiple myeloma (SMM) will be made in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group. These criteria include:
- Absence of hypercalcemia: Calcium less than or equal to 10.5 mg/dl
- Absence of lytic bone lesion (skeletal survey)
- The diagnoses will be confirmed by serum/urine protein electrophoresis, immunofixation and light-chain assays; as well as immunohistochemical analyses of the bone marrow biopsy.
- Age greater than or equal to 18 years.
Key exclusion criteria (28 listed)
- Patients with a diagnosis of multiple myeloma (MM) or a clinical suspicion of an ongoing progression into full-blown MM
- Patients without measurable disease defined as serum monoclonal protein (M-protein) less than 1 g/dL.
- Previous treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, immunomodulatory drugs (IMiDs), or proteasome inhibitors).
- Use of any investigational agent within the last 3 months.
- Clinical laboratory values at screening:
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 |
|---|---|---|
| (Anti-KIR)Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles | Drug | anti-KIR in Smoldering Multiple Myeloma Patients |
Primary outcome
Response Rate
Time frame: 1 year
Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR >25% and <50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium >2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin <10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.
1 secondary outcome
Count of Participants With Serious and Non-Serious Adverse Events
Time frame: Date treatment consent signed to date off study, approximately 3 years and 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17972944Anderson KC, Kyle RA, Rajkumar SV, Stewart AK, Weber D, Richardson P; ASH/FDA Panel on Clinical Endpoints in Multiple Myeloma. Clinically relevant end points and new drug approvals for myeloma. Leukemia. 2008 Feb;22(2):231-9. doi: 10.1038/sj.leu.2405016. Epub 2007 Nov 1.
- Background: PubMed 17420512Kristinsson SY, Landgren O, Dickman PW, Derolf AR, Bjorkholm M. Patterns of survival in multiple myeloma: a population-based study of patients diagnosed in Sweden from 1973 to 2003. J Clin Oncol. 2007 May 20;25(15):1993-9. doi: 10.1200/JCO.2006.09.0100. Epub 2007 Apr 9.
- Background: PubMed 19179464Landgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, Dispenzieri A, Kumar S, Clark RJ, Baris D, Hoover R, Rajkumar SV. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009 May 28;113(22):5412-7. doi: 10.1182/blood-2008-12-194241. Epub 2009 Jan 29.
- Results publication: PubMed 24658821Korde N, Carlsten M, Lee MJ, Minter A, Tan E, Kwok M, Manasanch E, Bhutani M, Tageja N, Roschewski M, Zingone A, Costello R, Mulquin M, Zuchlinski D, Maric I, Calvo KR, Braylan R, Tembhare P, Yuan C, Stetler-Stevenson M, Trepel J, Childs R, Landgren O. A phase II trial of pan-KIR2D blockade with IPH2101 in smoldering multiple myeloma. Haematologica. 2014 Jun;99(6):e81-3. doi: 10.3324/haematol.2013.103085. Epub 2014 Mar 21. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mark J Roschewski, M.D. 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?
A Phase 2 study testing (Anti-KIR) in people with Multiple Myeloma and Myeloma, 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 11 inclusion and 28 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 19 Nov 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2015). 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?
Response Rate (time frame: 1 year). 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 NCT01248455, which also lists 4 linked publications.
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 19 Nov 2019.