Hematologic NeoplasmsMATTERNCT03288441
Management and Outcomes of Anti-thrombotic Medication Use in Thrombocytopenia
An observational study of Hematologic Neoplasms and Thrombocytopenia, run by Maastricht University Medical Center at 21 sites in 4 countries.
Trial summary
Background: Antithrombotic therapy in the context of treatment related thrombocytopenia (i.e. low levels of platelets) is not uncommon. Guidelines are based upon a paucity of retrospective data and focus on the scenario of cancer associated venous thrombosis and low molecular weight heparin treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms, Thrombocytopenia, Anticoagulants
- What is being tested?
- Hold, Prophylactic dose antithrombotic and Change antithrombotic Drug
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 20 Mar 2018to 31 Dec 2021
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects treated at the inpatient or outpatient hematology departments at the participating centers
Who may be able to join
- Any hematological malignancy with or without active treatment (including autologous or allogeneic stem cell transplantation), irrespective of the treatment line and disease status.
- Disease-related and/or current/predicted treatment-related thrombocytopenia (<50 X 109/L) of any duration.
- Current antiplatelet and/or anticoagulant treatment of any duration and for any indication. This treatment may have been started before or after diagnosis of the hematological malignancy and thrombocytopenia.
- "Current" refers to the time when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped)
Who cannot join
- Previous thrombocytopenia (<50 X 109/L) while using the current antithrombotic regimen.
- Current diagnosis of heparin induced thrombocytopenia (HIT) or thrombotic thrombocytopenia purpura (TTP)
Trial locations and contacts
21 sites in 4 countries.
Hugo ten Cate, MD, PhD contact
21 sites in 4 countries
Italy11 sites, 11 recruiting
- Recruiting
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo di Alessandria
Alessandria, 15121
Dr. Roberto Santi, +39 (0)131 206111, dr.rsanti@gmail.com
- Recruiting
A.O. Papa Giovanni XXIII - S.I.M.T.
Bergamo, 24127
Anna Falanga, MD, +39-035.267.8597, annafalanga@icthic.com
Alessandro Rambaldi, MD, arambaldi@asst-pg23.it
- Recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
Dr. Giuseppe Rossi, +39 (0)30 399 8870, giuseppe.rossi@asst-spedalicivili.it
- Not yet recruiting
A.O.U. di Modena
Modena, 41125
Dr. Marco Marietta, +39 (0)59 422 2111, marco.marietta1@gmail.com
- Recruiting
Ospedale San Gerardo di Monza
Monza
Andrea Carrer, mail.carrer@gmail.com
- Recruiting
University Hospital Policlinico di Palermo
Palermo
Sergio Siragusa, MD
Mariasanta Napolitano, +39-91 655 1111, mariasanta.napolitano@unipa.it
- Recruiting
A.O.U Policlinico Umberto I di Roma
Roma, 00161
Dr. Antonio Chistolini, +39 06 49971, chistolini@bce.uniroma1.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Prof. Valerio De Stefano, +39 06 30151, valerio.destefano@unicatt.it
- Recruiting
Università degli studi di Roma "Tor Vergata"
Roma
Maria Ilaria Del Principe, Del.Principe@Med.uniroma2.it
- Recruiting
A.O.U. CITTA' della SALUTE e della SCIENZA di TORINO
Torino
Eloise Beggiato, MD, +39-11 633 1633, ebeggiato@cittadellasalute.to.it
- Not yet recruiting
AZIENDA ULSS N. 8 BERICA di Vicenza
Vicenza, 36100
Dr. Marco Ruggeri, +39 (0)444 753111, marco.ruggeri@ulssvicenza.it
Netherlands5 sites, 4 recruiting
- Recruiting
Amsterdam University Medical Centers
Amsterdam
Harry R Büller, MD, PhD, h.r.buller@amc.uva.nl
Eva N Hamulyák, MD, +31 20 5667516, e.n.hamulyak@amc.uva.nl
- Recruiting
University Medical Center Groningen
Groningen
Karina Meijer, MD, PhD, k.meijer@umcg.nl
Tessa Elling, MD, +31 6 31623491, t.elling@umcg.nl
- Recruiting
Maastricht University Medical Center (MUMC+)
Maastricht, 6229 HX
Avi Leader, MD, +31-43-3874780, avileader@yahoo.com
- Recruiting
Erasmus Medical Center
Rotterdam
Mandy Lauw, MD, PhD, m.lauw@erasmusmc.nl
- Withdrawn
HagaZiekenhuis
The Hague, 2545 AA
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Yona Nadir, MD, PhD
Debbie Steiner, MHA, +972-4-8543592, d_steiner@rambam.health.gov.il
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
Orly Avnery, MD, +972-9-7471755, avneryho@clalit.org.il
- Recruiting
Rabin Medical Center
Petah Tikva
Galia Spectre, MD, PhD, +972-3-9377906, galiasp1@clalit.org.il
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Ron Ram, MD, +972-3-697-3577, ronr@tlvmc.gov.il
United States1 site
- Terminated
Oregon Health & Science University Hospital
Portland, Oregon, 97239
About this study
Official title: Management Patterns of AntiThrombotics and Outcomes in Patients With Hematological Malignancy and ThrombocytopEnia: a Prospective Registry (MATTER Study)
Background: Antithrombotic therapy in the context of treatment related thrombocytopenia (i.e. low levels of platelets) is not uncommon. Guidelines are based upon a paucity of retrospective data and focus on the scenario of cancer associated venous thrombosis and low molecular weight heparin treatment. Even less is known regarding direct oral anticoagulants, antiplatelet therapy, or anticoagulation prescribed for other indications.
Aims: The study aims are to evaluate how physicians manage anticoagulant and antiplatelet medication in patients with hematological malignancy and thrombocytopenia, and to assess the frequency of bleeding and thrombosis. Additional aims are to assess how management changes affect drug activity and blood clotting (coagulation), and to evaluate the use of platelet transfusions.
Read more
Design: The investigators plan a multinational prospective registry of patients admitted to the inpatient hematology department or outpatient clinic at one of the study centers. Patients with hematological malignancies, platelets below 50 X 109/L, and anticoagulant and/or antiplatelet medication will be studied.
Patients will be enrolled when the combination of antiplatelet/anticoagulant medication and thrombocytopenia is first detected. Patients will be followed until 30 days after the baseline study visit (which occurs 30 days after enrollment or when platelets < 50*109/L, whichever come first) or death. Patients will be indexed at the time of baseline visit.
Patients will be excluded from study analysis if one of the following events occurs before study index: Withdrawal of consent, death, clinically-relevant non-major bleeding or the composite primary outcome.
Risk factors for bleeding and thrombosis will be recorded at baseline. Parameters from routine blood tests will be recorded throughout the study. During the study major bleeding events and thrombosis will be recorded. Investigational blood tests assessing coagulation and drug activity will be drawn at baseline (=study index). Throughout the study all management decisions regarding antithrombotic therapy, including platelet and red blood cell transfusion, will be recorded. This is an observational study and management will be solely at the discretion of the physician.
Analysis: The investigators will first look at the frequency of either bleeding or thrombosis according to the type of management strategy and evaluate the platelet threshold at which a given management strategy is employed.
At the next stage, in selected subgroups, the optimal management strategy with respect to bleeding/thrombotic risk, will be determined.
Read the detailed description
- Thrombocyte-level cohorts Patients will be divided into two groups based on the platelet level at study index .
- Thrombocytopenic Cohort: Patients with morning platelet count below 50*109/L at study index. This is the main study cohort for all analyses
- Non-thrombocytopenic Cohort: Patients whose morning platelet count is ≥ 50*109/L at study index will be considered as a reference group, and not included in the primary analysis.
- Analysis of outcomes:
By definition, there will be an intervention at the time of study index (baseline), meaning that even if no change is made, it will be considered an intervention. Each patient may have multiple exposures/interventions over the study.
Therefore, in a time dependent analysis, each outcome will be linked to the exposure/intervention at study index.
Each exposure/intervention will be linked with the platelet level on the day of the intervention.
#Competing Events:
The following events (in addition to death) will be considered competing events and will be considered as such in the statistical analyses of the outcomes:
- The composite primary outcome
- change in the antithrombotic regimen after study index
- diagnosis of HIT or TTP
- a change in the hematological malignancy treatment regimen. Study follow-up will continue after these events, and study data will continue to be recorded until censorship for end of study period or death.
- Detecting selection bias:
Patients fulfilling the inclusion criteria but not included in the study, will be detected by reviewing the medical records of the hematology institute, weekly. The baseline characteristics and reason for not including these patients will be recorded retrospectively in the "not-included cohort". The baseline characteristics of this cohort will be compared with the study cohort to ascertain whether selection bias exists.
- Being tested
- Hold, Prophylactic dose antithrombotic, Change antithrombotic Drug, Change platelet transfusion threshold, Full dose antithrombotics
- Keywords
- Hematologic Neoplasms, Thrombocytopenia, Anticoagulants, Platelet Aggregation Inhibitors
- Medical subject headings
- Hematologic Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoldDrug
Hold antithrombotic therapy
Prophylactic dose antithromboticDrug
Reduction in antithrombotic medication dose to prophylactic dose (without changing type)
Change antithrombotic DrugDrug
Change in type of antithrombotic therapy
Change platelet transfusion thresholdBiological
Increase or reduce platelet transfusion threshold
Full dose antithromboticsDrug
Continue full dose antithrombotic therapy
Mechanical measuresDevice
Mechanical measures to reduce thrombotic risk including: IVC filter insertion, Intermittent Pneumatic Compression (IPC), Removal of Central venous catheter
Intermediate dose antithromboticDrug
Reduction in antithrombotic medication dose to prophylactic dose (without changing type). Intermediate dose in between prophylactic and full dose
| Study group | Role | What they receive |
|---|---|---|
| antiplatelet only | Patients receiving antiplatelet medication, but not anticoagulation. Antiplatelet drugs include any class, dose or duration of any platelet aggregation inhibitor.
This refers to the antithrombotic regimen when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped) Receives: Drug: Hold; Drug: Change antithrombotic Drug; Biological: Change platelet transfusion threshold; Drug: Full dose antithrombotics | |
| anticoagulant-based | Patients receiving only anticoagulants or both anticoagulant and antiplatelet medication combined. This includes any class, dose or duration of any antiplatelet or anticoagulant drug.
This refers to the antithrombotic regimen when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped) Receives: Drug: Hold; Drug: Prophylactic dose antithrombotic; Drug: Change antithrombotic Drug; Biological: Change platelet transfusion threshold; Drug: Full dose antithrombotics; Device: Mechanical measures; Drug: Intermediate dose antithrombotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major bleeding or thrombosis
- ISTH-defined Major bleeding events defined as: Fatal bleeding; bleeding into a critical organ; clinically overt bleeding associated with a decrease in hemoglobin level of more than 2 g/dL or leading to the transfusion of two or more units of blood OR: 2) Thrombosis defined as: Any symptomatic deep or superficial venous or arterial thromboembolism demonstrated on objective imaging/laboratory tests. Ischemic strokes with no immediate imaging signs will also be considered events, provided this was diagnosed by a neurologist and that the patient had objective neurological signs.
Measured: 30 days (from study index) or until death (whichever first)
Secondary outcomes (6)
Platelet transfusion related adverse effects
Number of adverse effects (all types and individually grouped) related to platelet/plasma transfusion, occurring within 24 hours of transfusion
Measured: 30 days (from study index) or until death (whichever first)
Clinically Relevant non-Major Bleeding
Defined according to the ISTH criteria published in the journal of thrombosis and Hemostasis by Kaatz et al in 2015
Measured: 30 days (from study index) or until death (whichever first)
Number of platelet tranfusions
Number of platelet transfusions
Measured: 30 days (from study index) or until death (whichever first)
Number of RBC tranfusions
Number of red blood cell transfusions
Measured: 30 days (from study index) or until death (whichever first)
Death
death from any cause
Measured: 30 days (from study index)
Change in antithrombotic management
Change in dose/type of antiplatelet or anticoagulant medication OR change in platelet threshold, AFTER the initial intervention which was recorded at study index.
Measured: 30 days (from study index) or until death (whichever first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start20 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Maastricht University 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
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avi Leader, MD, Principal investigator, Rabin Medical Center, Petah Tikva, IsraelHugo ten Cate, MD, PhD, Study chair, Maastricht University Medical Center, MaastrichtAnna Falanga, MD, Study chair, A.O. Papa Giovanni XXIII - S.I.M.T.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288441
- Sponsor's protocol ID
- METC 17-4-061
- Acronym
- MATTER
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Patterns of AntiThrombotics and Outcomes in Patients With Hematological Malignancy and ThrombocytopEnia: a Prospective Registry (MATTER Study)
- ClinicalTrials.gov ID
- NCT03288441
- Acronym / sponsor ID
- MATTER / METC 17-4-061
- Keywords
- Hematologic Neoplasms, Thrombocytopenia, Anticoagulants, Platelet Aggregation Inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Sep 2017 (actual)
- 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: Antithrombotic therapy in the context of treatment related thrombocytopenia (i.e. low levels of platelets) is not uncommon. Guidelines are based upon a paucity of retrospective data and focus on the scenario of cancer associated venous thrombosis and low molecular weight heparin treatment. Even less is known regarding direct oral anticoagulants, antiplatelet therapy, or anticoagulation prescribed for other indications.
Aims: The study aims are to evaluate how physicians manage anticoagulant and antiplatelet medication in patients with hematological malignancy and thrombocytopenia, and to assess the frequency of bleeding and thrombosis. Additional aims are to assess how management changes affect drug activity and blood clotting (coagulation), and to evaluate the use of platelet transfusions.
Design: The investigators plan a multinational prospective registry of patients admitted to the inpatient hematology department or outpatient clinic at one of the study centers. Patients with hematological malignancies, platelets below 50 X 109/L, and anticoagulant and/or antiplatelet medication will be studied.
Patients will be enrolled when the combination of antiplatelet/anticoagulant medication and thrombocytopenia is first detected. Patients will be followed until 30 days after the baseline study visit (which occurs 30 days after enrollment or when platelets < 50*109/L, whichever come first) or death. Patients will be indexed at the time of baseline visit.
Patients will be excluded from study analysis if one of the following events occurs before study index: Withdrawal of consent, death, clinically-relevant non-major bleeding or the composite primary outcome.
Risk factors for bleeding and thrombosis will be recorded at baseline. Parameters from routine blood tests will be recorded throughout the study. During the study major bleeding events and thrombosis will be recorded. Investigational blood tests assessing coagulation and drug activity will be drawn at baseline (=study index). Throughout the study all management decisions regarding antithrombotic therapy, including platelet and red blood cell transfusion, will be recorded. This is an observational study and management will be solely at the discretion of the physician.
Analysis: The investigators will first look at the frequency of either bleeding or thrombosis according to the type of management strategy and evaluate the platelet threshold at which a given management strategy is employed.
At the next stage, in selected subgroups, the optimal management strategy with respect to bleeding/thrombotic risk, will be determined.
Detailed description
- Thrombocyte-level cohorts Patients will be divided into two groups based on the platelet level at study index .
- Thrombocytopenic Cohort: Patients with morning platelet count below 50*109/L at study index. This is the main study cohort for all analyses
- Non-thrombocytopenic Cohort: Patients whose morning platelet count is ≥ 50*109/L at study index will be considered as a reference group, and not included in the primary analysis.
- Analysis of outcomes:
By definition, there will be an intervention at the time of study index (baseline), meaning that even if no change is made, it will be considered an intervention. Each patient may have multiple exposures/interventions over the study.
Therefore, in a time dependent analysis, each outcome will be linked to the exposure/intervention at study index.
Each exposure/intervention will be linked with the platelet level on the day of the intervention.
#Competing Events:
The following events (in addition to death) will be considered competing events and will be considered as such in the statistical analyses of the outcomes:
- The composite primary outcome
- change in the antithrombotic regimen after study index
- diagnosis of HIT or TTP
- a change in the hematological malignancy treatment regimen. Study follow-up will continue after these events, and study data will continue to be recorded until censorship for end of study period or death.
- Detecting selection bias:
Patients fulfilling the inclusion criteria but not included in the study, will be detected by reviewing the medical records of the hematology institute, weekly. The baseline characteristics and reason for not including these patients will be recorded retrospectively in the "not-included cohort". The baseline characteristics of this cohort will be compared with the study cohort to ascertain whether selection bias exists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antiplatelet only | – | Drug: Hold, Drug: Change antithrombotic Drug, Biological: Change platelet transfusion threshold, Drug: Full dose antithromboticsPatients receiving antiplatelet medication, but not anticoagulation. Antiplatelet drugs include any class, dose or duration of any platelet aggregation inhibitor. This refers to the antithrombotic regimen when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped) |
| anticoagulant-based | – | Drug: Hold, Drug: Prophylactic dose antithrombotic, Drug: Change antithrombotic Drug, Biological: Change platelet transfusion threshold, Drug: Full dose antithrombotics, Device: Mechanical measures, Drug: Intermediate dose antithromboticPatients receiving only anticoagulants or both anticoagulant and antiplatelet medication combined. This includes any class, dose or duration of any antiplatelet or anticoagulant drug. This refers to the antithrombotic regimen when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects treated at the inpatient or outpatient hematology departments at the participating centers
Key inclusion criteria (4 listed)
- Any hematological malignancy with or without active treatment (including autologous or allogeneic stem cell transplantation), irrespective of the treatment line and disease status.
- Disease-related and/or current/predicted treatment-related thrombocytopenia (<50 X 109/L) of any duration.
- Current antiplatelet and/or anticoagulant treatment of any duration and for any indication. This treatment may have been started before or after diagnosis of the hematological malignancy and thrombocytopenia.
- "Current" refers to the time when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped)
Key exclusion criteria (2 listed)
- Previous thrombocytopenia (<50 X 109/L) while using the current antithrombotic regimen.
- Current diagnosis of heparin induced thrombocytopenia (HIT) or thrombotic thrombocytopenia purpura (TTP)
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 |
|---|---|---|
| HoldHold antithrombotic therapy | Drug | anticoagulant-based, antiplatelet only |
| Prophylactic dose antithromboticReduction in antithrombotic medication dose to prophylactic dose (without changing type) | Drug | anticoagulant-based |
| Change antithrombotic DrugChange in type of antithrombotic therapy | Drug | anticoagulant-based, antiplatelet only |
| Change platelet transfusion thresholdIncrease or reduce platelet transfusion threshold | Biological | anticoagulant-based, antiplatelet only |
| Full dose antithromboticsContinue full dose antithrombotic therapy | Drug | anticoagulant-based, antiplatelet only |
| Mechanical measuresMechanical measures to reduce thrombotic risk including: IVC filter insertion, Intermittent Pneumatic Compression (IPC), Removal of Central venous catheter | Device | anticoagulant-based |
| Intermediate dose antithromboticReduction in antithrombotic medication dose to prophylactic dose (without changing type). Intermediate dose in between prophylactic and full dose | Drug | anticoagulant-based |
Primary outcome
Composite of major bleeding or thrombosis
Time frame: 30 days (from study index) or until death (whichever first)
1) ISTH-defined Major bleeding events defined as: Fatal bleeding; bleeding into a critical organ; clinically overt bleeding associated with a decrease in hemoglobin level of more than 2 g/dL or leading to the transfusion of two or more units of blood OR: 2) Thrombosis defined as: Any symptomatic deep or superficial venous or arterial thromboembolism demonstrated on objective imaging/laboratory tests. Ischemic strokes with no immediate imaging signs will also be considered events, provided this was diagnosed by a neurologist and that the patient had objective neurological signs.
6 secondary outcomes
Platelet transfusion related adverse effects
Time frame: 30 days (from study index) or until death (whichever first)
Clinically Relevant non-Major Bleeding
Time frame: 30 days (from study index) or until death (whichever first)
Number of platelet tranfusions
Time frame: 30 days (from study index) or until death (whichever first)
Number of RBC tranfusions
Time frame: 30 days (from study index) or until death (whichever first)
Death
Time frame: 30 days (from study index)
Change in antithrombotic management
Time frame: 30 days (from study index) or until death (whichever first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
Related trials for Hematologic Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Hugo ten Cate, MD, PhD contact
Avi Leader, MD principal investigator
Rabin Medical Center, Petah Tikva, Israel
Hugo ten Cate, MD, PhD study chair
Maastricht University Medical Center, Maastricht
Anna Falanga, MD study chair
A.O. Papa Giovanni XXIII - S.I.M.T.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Neoplasms and Thrombocytopenia, run by Maastricht University Medical Center at 21 sites in 4 countries.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy, Netherlands, Israel, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avi Leader, MD (+972-3-9377906, avileader@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major bleeding or thrombosis (time frame: 30 days (from study index) or until death (whichever first)). 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 17 Sep 2020.