Multiple Myeloma
Conditions
Keywords
Without detection of deletion 17p or translocation 4;14;, Post Cyclophosphamide, GvHD Prophylaxis, Allogeneic SCT
Brief 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.
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.
Interventions
DRUGCyclophosphamide
Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
Sponsors
Esteve Pharmaceuticals GmbH
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation 2. Patients age: 18 - 65 years at time of inclusion (female and male) 3. Performance status ECOG \< 2 4. Availability of haploidentical, matched or mismatched related or unrelated donor 5. Patients understand and voluntarily sign an informed consent 6. 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). 7. 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.
Exclusion criteria
1. Severe active infection or other uncontrolled severe conditioning 2. 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 3. Positive serology for HIV 4. Pregnant or lactating women (positive serum pregnancy test) 5. Women of child-bearing potential with unclear contraception 6. Age \< 18 and \> 65 years. 7. Uncontrolled invasive fungal infection at time of screening (baseline) 8. Serious psychiatric or psychological disorders 9. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic GvHD | 2 years | Chronic GvHD at 2 years after allogeneic SCT |
| Progression-free survival | 2 years | Progression-free survival at 2 years after allogeneic SCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic GvHD | 1 and 2 years after allogeneic SCT | Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT |
| Toxicity of cyclophosphamide | till 2 years | Toxicity scored according to NCI CTCAE, Version 4.0 |
| Non-relapsed mortality | 2 years | Non-relapsed mortality at 2 years after allogeneic SCT |
| Overall Survival | 2 years | Overall survival at 2 years |
| Progression-free Survival | 2 years | Progression-free survival at 2 years |
| Remission rate | till 2 years | Complete remission rate (including sCR and MRD negativity) |
| Acute GvHD | Day +100 after allogeneic SCT | Incidence of acute GvHD on Day +100 after allogeneic SCT |
Countries
Germany
Outcome results
None listed