Multiple MyelomaPhase 2NCT03700450
Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma
A Phase 2 study testing Cyclophosphamide in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
Trial summary
The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesGermany
- Study dates
- 16 Mar 2018to 1 Dec 2022
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation
- Patients age: 18 - 65 years at time of inclusion (female and male)
- Performance status ECOG < 2
- Availability of haploidentical, matched or mismatched related or unrelated donor
- Patients understand and voluntarily sign an informed consent
- The study population includes female of childbearing potential (FOCP). FOCP have to agree to comply with the applicable contraceptive requirements of the protocol as named below for the duration of the study and 6 months after end of study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization).
- Men who are sexually active with FOCP must be instructed to use male contraception (condom) in order to avoid exposure of an existing embryo/fetus. Contraception should be continued until 6 months after end of study.
Who cannot join
- Severe active infection or other uncontrolled severe conditioning
- Severe renal, hepatic, pulmonary or cardiac disease, such as:
- Total bilirubin, SGPT or SGOT > 3 times upper the normal level
- Left ventricular ejection fraction < 30 %
- Creatinine clearance < 30 ml/min
- DLCO < 35 % and/or receiving supplementary continuous oxygen
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- Positive serology for HIV
- Pregnant or lactating women (positive serum pregnancy test)
- Women of child-bearing potential with unclear contraception
- Age < 18 and > 65 years.
- Uncontrolled invasive fungal infection at time of screening (baseline)
- Serious psychiatric or psychological disorders
- Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
About this study
Official title: Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study)
The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.
Read the detailed description
The present study is a multicenter, prospective Phase II-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group.
In this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.
- Conditions
- Multiple Myeloma
- Being tested
- Cyclophosphamide
- Keywords
- Without detection of deletion 17p or translocation 4;14;, Post Cyclophosphamide, GvHD Prophylaxis, Allogeneic SCT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Endoxan
Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamid post Tranplant | Experimental | Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic GvHD
Chronic GvHD at 2 years after allogeneic SCT
Measured: 2 years
Progression-free survival
Progression-free survival at 2 years after allogeneic SCT
Measured: 2 years
Secondary outcomes (7)
Non-relapsed mortality
Non-relapsed mortality at 2 years after allogeneic SCT
Measured: 2 years
Acute GvHD
Incidence of acute GvHD on Day +100 after allogeneic SCT
Measured: Day +100 after allogeneic SCT
Chronic GvHD
Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT
Measured: 1 and 2 years after allogeneic SCT
Toxicity of cyclophosphamide
Toxicity scored according to NCI CTCAE, Version 4.0
Measured: till 2 years
Remission rate
Complete remission rate (including sCR and MRD negativity)
Measured: till 2 years
Overall Survival
Overall survival at 2 years
Measured: 2 years
Progression-free Survival
Progression-free survival at 2 years
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 posted9 Oct 2018
- Study start16 Mar 2018
- Primary completion22 Nov 2022
- Study completion1 Dec 2022
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.
- 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
- Model description
- All patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Esteve Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Nicolaus Kröger, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700450
- Sponsor's protocol ID
- Allo-MM-PostCy-Study
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2018
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study)
- ClinicalTrials.gov ID
- NCT03700450
- Acronym / sponsor ID
- Allo-MM-PostCy-Study
- Conditions
- Multiple Myeloma
- Keywords
- Without detection of deletion 17p or translocation 4;14;, Post Cyclophosphamide, GvHD Prophylaxis, Allogeneic SCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Esteve Pharmaceuticals GmbH
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 9 Oct 2018 (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.
The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.
Detailed description
The present study is a multicenter, prospective Phase II-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group.
In this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamid post Tranplant | Experimental | Drug: CyclophosphamidePatients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation
- Patients age: 18 - 65 years at time of inclusion (female and male)
- Performance status ECOG < 2
- Availability of haploidentical, matched or mismatched related or unrelated donor
- Patients understand and voluntarily sign an informed consent
Key exclusion criteria (13 listed)
- Severe active infection or other uncontrolled severe conditioning
- Severe renal, hepatic, pulmonary or cardiac disease, such as:
- Positive serology for HIV
- Pregnant or lactating women (positive serum pregnancy test)
- Women of child-bearing potential with unclear contraception
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 |
|---|---|---|
| CyclophosphamideAlso: EndoxanPatients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide | Drug | Cyclophosphamid post Tranplant |
Primary outcome
Chronic GvHD
Time frame: 2 years
Chronic GvHD at 2 years after allogeneic SCT
Progression-free survival
Time frame: 2 years
Progression-free survival at 2 years after allogeneic SCT
7 secondary outcomes
Non-relapsed mortality
Time frame: 2 years
Acute GvHD
Time frame: Day +100 after allogeneic SCT
Chronic GvHD
Time frame: 1 and 2 years after allogeneic SCT
Toxicity of cyclophosphamide
Time frame: till 2 years
Remission rate
Time frame: till 2 years
Overall Survival
Time frame: 2 years
Progression-free Survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- 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.
Nicolaus Kröger, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chronic GvHD (time frame: 2 years). The study lists 2 primary outcomes in all. 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 30 Mar 2025.