Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma
Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma
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.
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.
Inclusion Criteria:

 1. Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple
 myelo-ma 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 relative 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