Multiple MyelomaPhase 1/2NCT02519114
Haploidentical Bone Marrow Stem Cell Transplantation in Patients With Multiple Myeloma
A Phase 1/2 study testing Donor Bone Marrow stem cell transplantation in people with Multiple Myeloma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with post-transplant cyclophosphamide will improve progression free survival in poor risk multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Donor Bone Marrow stem cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Jun 2017
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with MM <60 years.
- Poor prognosis MM patients, permissive for KIR-ligand mismatch and with a KIR-ligand mismatched haploidentical donor. Poor prognosis is based on:
- Patients with early disease recurrence (within 12 months after first ASCT) or
- Patients after a minimum of three lines of chemotherapy (including high dose therapy followed by ASCT rescue therapy) or
- Poor risk based on the cytogenetic profile.
- Written informed consent
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- No HLA identical related or 10/10 matched unrelated donor
- Permissive for KIR-ligand mismatch
- Responsive after reinduction therapy
- Measurable disease
Who cannot join
- - Patients with an full matched (10/10) donor, who will enroll in the HOVON 96 study
- Active uncontrolled infections
- Uncontrolled CNS involvement by the malignant disease
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
- Severe pulmonary dysfunction (CTCAE grade III-IV)
- Severe neurological or psychiatric disease
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- Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal)
- Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration)
- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- Any psychological, familial, lingual, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Breast-feeding female patients.
- Concurrent severe and/or uncontrolled medical condition (DM, hypertension, cancer).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht university Medical center
Maastricht
Janine Van Elssen, MD, PhD, janine.van.elssen@mumc.nl
Gerard Bos, MD, PhD, gerard.bos@mumc.nl
About this study
Official title: Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma
The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with post-transplant cyclophosphamide will improve progression free survival in poor risk multiple myeloma patients.
Read the detailed description
The goal of this study is to evaluate the effectiveness of a new treatment modality, the KIR-ligand mismatched haploidentical stem cell transplantation (haploBMT), for poor risk multiple myeloma (MM) patients. MM is a malignancy of plasma cells that usually resides in the bone marrow. Despite new treatment modalities that have been introduced in the last years, MM is still an incurable disease for most patients and median survival for the younger patients (<65) is about 5 years. MM can be treated by several disease modifiers - classical chemotherapy, high dose chemotherapy and autologous stem cell transplantation (ASCT), immunomodulators like thalidomide and lenalidomide, and drugs like bortezomib that interact with relevant intracellular pathways of malignant plasma cells. Though these treatment modalities have improved overall survival and quality of life, patients are not cured.
- Conditions
- Multiple Myeloma
- Being tested
- Donor Bone Marrow stem cell transplantation
- Keywords
- M Myeloma, KIR ligand mismatch, Haploidentical
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor Bone Marrow stem cell transplantationProcedure or surgery
KIR-mismatched haploidentical Bone Marrow stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Bone MarrowTransplantation | Experimental | KIR-mismatched haploidentical bone marrow transplantation Receives: Procedure: Donor Bone Marrow stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (scale)
Measured: 1 year
Secondary outcomes (9)
Response rate (scale)
Measured: analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation
Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology)
Measured: 30 days after transplantation
Incidence and Severity of Acute and Chronic GVHD (scale)
Measured: analyzed during follow-up of 1,5 years
Non-Relapse Mortality (number)
Measured: 1.5 years
Evaluation of infections after haploBMT and T cell reconstitution (scale)
Measured: 1 year after transplantation
NK cell repertoire reconstitution and maturation rates including alloreactivity (facs)
Measured: 1 year after transplantation
NK cell repertoire in the Bone Marrow before and after transplantation (facs)
Measured: 6 weeks after transplantation
Cost calculation (euro)
Measured: 1.5 years
Quality of Life (questionnaire)
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerard Bos, Maastricht University Medical Center
- Investigators
- Claudia Geesing, Study director, Maastricht Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519114
- Sponsor's protocol ID
- NL49476.000
- Status last verified
- Feb 2017
- First submitted
- 28 May 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Van Elssen C, van Gorkom G, Voorter C, von dem Borne P, Meijer E, Wieten L, Bos G. Haploidentical transplantation in patients with multiple myeloma making use of natural killer cell alloreactive donors. Ann Hematol. 2021 Jan;100(1):181-187. doi: 10.1007/s00277-020-04303-z. Epub 2020 Oct 28.
PubMed 33112968
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Killer Cel Alloreactive Bone Marrow Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02519114
- Acronym / sponsor ID
- NL49476.000
- Conditions
- Multiple Myeloma
- Keywords
- M Myeloma, KIR ligand mismatch, Haploidentical
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Aug 2015 (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 aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with post-transplant cyclophosphamide will improve progression free survival in poor risk multiple myeloma patients.
Detailed description
The goal of this study is to evaluate the effectiveness of a new treatment modality, the KIR-ligand mismatched haploidentical stem cell transplantation (haploBMT), for poor risk multiple myeloma (MM) patients. MM is a malignancy of plasma cells that usually resides in the bone marrow. Despite new treatment modalities that have been introduced in the last years, MM is still an incurable disease for most patients and median survival for the younger patients (<65) is about 5 years. MM can be treated by several disease modifiers - classical chemotherapy, high dose chemotherapy and autologous stem cell transplantation (ASCT), immunomodulators like thalidomide and lenalidomide, and drugs like bortezomib that interact with relevant intracellular pathways of malignant plasma cells. Though these treatment modalities have improved overall survival and quality of life, patients are not cured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone MarrowTransplantation | Experimental | Procedure: Donor Bone Marrow stem cell transplantationKIR-mismatched haploidentical bone marrow transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients with MM <60 years.
- Poor prognosis MM patients, permissive for KIR-ligand mismatch and with a KIR-ligand mismatched haploidentical donor. Poor prognosis is based on:
- Written informed consent
- No HLA identical related or 10/10 matched unrelated donor
- Permissive for KIR-ligand mismatch
Key exclusion criteria (12 listed)
- - Patients with an full matched (10/10) donor, who will enroll in the HOVON 96 study
- Active uncontrolled infections
- Uncontrolled CNS involvement by the malignant disease
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
- Severe pulmonary dysfunction (CTCAE grade III-IV)
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 |
|---|---|---|
| Donor Bone Marrow stem cell transplantationKIR-mismatched haploidentical Bone Marrow stem cell transplantation | Procedure or surgery | Bone MarrowTransplantation |
Primary outcome
Progression free survival (scale)
Time frame: 1 year
9 secondary outcomes
Response rate (scale)
Time frame: analyzed at -7, 30, 60, 90, 120, 150, 180, 270 and 360 days post-transplatation
Incidence of graft failure, engraftment and time to neutrophil and platelet recovery (hematology)
Time frame: 30 days after transplantation
Incidence and Severity of Acute and Chronic GVHD (scale)
Time frame: analyzed during follow-up of 1,5 years
Non-Relapse Mortality (number)
Time frame: 1.5 years
Evaluation of infections after haploBMT and T cell reconstitution (scale)
Time frame: 1 year after transplantation
NK cell repertoire reconstitution and maturation rates including alloreactivity (facs)
Time frame: 1 year after transplantation
NK cell repertoire in the Bone Marrow before and after transplantation (facs)
Time frame: 6 weeks after transplantation
Cost calculation (euro)
Time frame: 1.5 years
Quality of Life (questionnaire)
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Derived from this study: PubMed 33112968Van Elssen C, van Gorkom G, Voorter C, von dem Borne P, Meijer E, Wieten L, Bos G. Haploidentical transplantation in patients with multiple myeloma making use of natural killer cell alloreactive donors. Ann Hematol. 2021 Jan;100(1):181-187. doi: 10.1007/s00277-020-04303-z. Epub 2020 Oct 28.
- 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.
Claudia Geesing study director
Maastricht Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Donor Bone Marrow stem cell transplantation in people with Multiple Myeloma, run by Maastricht University Medical Center at 1 site in Netherlands.
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 10 inclusion and 12 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 10 Feb 2017. 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 Netherlands. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janine Elssen van, MD PhD (31 43 3877026, janine.van.elssen@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (scale) (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 NCT02519114, which also lists 1 linked publication.
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 10 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.