Multiple MyelomaPhase 2OCTET-CYNCT01283776
Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
A Phase 2 study testing Cyclophosphamide in people with Multiple Myeloma and Non-Hodgkin-Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease
- What is being tested?
- Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning
- Written informed consent
- No uncontrolled infections
Who cannot join
- Severe organ dysfunction defined as:
- Cardiac left ventricular ejection fraction (LVEF) of less than 35%
- diffusing lung capacity (DLCO) of less than 40%
- total lung capacity (TLC) of less than 40%
- forced expiratory volume (FEV1) of less than 40%
- total bilirubin >3mg/dl
Show all 9Show fewer
- creatinine-clearance of less than 40 ml/min
- pregnancy or breast feeding
- participation in other experimental drug trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
- Conditions
- Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease
- Being tested
- Cyclophosphamide
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Cyclophosphamide Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients not requiring additional immunosuppression
The primary endpoint is met if at least 1 of the 5 first patients and 3 of a total of 11 patient will reach day 100 after transplant without additional immunsuppressive drug treatment
Measured: day 100 after transplant
Secondary outcomes (7)
Overall Survival
Measured: day 100 after transplant
engraftment
absolute neutrophil count of > 0.5 x 10e9/l on 3 consecutive days
Measured: day 100 after transplant
chimerism
Percentage of donor cells in leukocytes from peripheral blood or bone marrow
Measured: day 100 after transplant
relapse incidence
cumulative incidence of relapse until day 100
Measured: day 100 after transplant
acute GvHD
cumulative incidence of acute GvHD
Measured: day 100 after transplant
non-relapse mortality
cumulative incidence of death from any cause without prior relapse or progression of malignant disease
Measured: day 100 after transplant
immune reconstitution
relative and absolute counts of B- and T-lymphocyte subsets in peripheral blood
Measured: day 100 after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionJun 2014
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Scheid, University of Cologne
- Investigators
- Christoph Scheid, MD PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283776
- Sponsor's protocol ID
- Uni-Koeln-1430
- Acronym
- OCTET-CY
- Status last verified
- Jun 2014
- First submitted
- 25 Jan 2011
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01283776
- Acronym / sponsor ID
- OCTET-CY / Uni-Koeln-1430
- Conditions
- Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jan 2011 (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.
A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: CyclophosphamideCyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning
Key exclusion criteria (9 listed)
- Severe organ dysfunction defined as:
- Cardiac left ventricular ejection fraction (LVEF) of less than 35%
- diffusing lung capacity (DLCO) of less than 40%
- total lung capacity (TLC) of less than 40%
- forced expiratory volume (FEV1) of less than 40%
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 |
|---|---|---|
| Cyclophosphamide100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation | Drug | treatment arm |
Primary outcome
Number of patients not requiring additional immunosuppression
Time frame: day 100 after transplant
The primary endpoint is met if at least 1 of the 5 first patients and 3 of a total of 11 patient will reach day 100 after transplant without additional immunsuppressive drug treatment
7 secondary outcomes
Overall Survival
Time frame: day 100 after transplant
engraftment
Time frame: day 100 after transplant
chimerism
Time frame: day 100 after transplant
relapse incidence
Time frame: day 100 after transplant
acute GvHD
Time frame: day 100 after transplant
non-relapse mortality
Time frame: day 100 after transplant
immune reconstitution
Time frame: day 100 after transplant
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 10 Jun 2014.
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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.
Christoph Scheid, MD PhD principal investigator
University of Cologne
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 Cyclophosphamide in people with Multiple Myeloma and Non-Hodgkin-Lymphoma, run by University of Cologne at 1 site 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 3 inclusion and 9 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 10 Jun 2014. 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 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?
Number of patients not requiring additional immunosuppression (time frame: day 100 after transplant). 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 10 Jun 2014.