Clinical trial NCT03700450: Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma
Official title: Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Without detection of deletion 17p or translocation 4;14;
Post Cyclophosphamide
GvHD Prophylaxis
Allogeneic SCT
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Esteve Pharmaceuticals GmbH
First posted: 2018-10-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic GvHD
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Non-relapsed mortality
timeFrame: 2 years
measure: Acute GvHD
timeFrame: Day +100 after allogeneic SCT
measure: Chronic GvHD
timeFrame: 1 and 2 years after allogeneic SCT
measure: Toxicity of cyclophosphamide
timeFrame: till 2 years
measure: Remission rate
timeFrame: till 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Progression-free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Nicolaus Kröger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: