Clinical trial NCT01665014: Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma
Official title: Efficacy and Safety of Double Autologous Hematopoietic Stem Cell Transplantation With Sequential Use of Total Marrow Irradiation and High-dose Melphalan in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: autologous hematopoietic stem cell transplantation
total marrow irradiation
melphalan
multiple myeloma
Lead sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 50
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
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM).

Detailed description: AutoHSCT is a standard treatment of patients with MM. According to soem clinical evidence double autoHSCT provides survival advantage compared to a single procedure. Most frequently used conditioning regimen consists pf high doses of melphalan (HD-MEL). In some studies it was used in combination with total body irradiation (TBI), which, however was associated with significant toxicity. In our center the standard procedure includes TBI as a single treatment at 1st autoHSCT and HD-Mel at 2nd autoHSCT.

As in MM malignant plasma cells are localized almost exclusively in bone marrow there is rationale to limit irradiation to bones. For this purpose in the current study we substitute TBI with TMI. Additional boosts are provided for active sites of disease based on PET/CT imaging. Our intention is to minimize toxicity while maintaining the treatment efficacy.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosis of multiple myeloma
* PR, VGPR or CR at inclusion
* Performance status WHO 0-1
* Written informed consent

Exclusion Criteria:

* Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine \>1.5 upper normal limit; LVEF \<45%
* Active infection
* Unstable diabetes
* Psychiatric diseases
* History of high-dose chemotherapy or irradiation
* Second malignancy
* Pregnancy

Primary outcomes:
measure: Progression-free survival
timeFrame: three years
Secondary outcomes:
measure: Rate of complete and very good partial responses
timeFrame: six months
Other outcomes:
measure: Rate of severe adverse events
timeFrame: one year
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Study officials:
affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
name: Sebastian Giebel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Somlo G, Spielberger R, Frankel P, Karanes C, Krishnan A, Parker P, Popplewell L, Sahebi F, Kogut N, Snyder D, Liu A, Schultheiss T, Forman S, Wong JY. Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma. Clin Cancer Res. 2011 Jan 1;17(1):174-82. doi: 10.1158/1078-0432.CCR-10-1912. Epub 2010 Nov 3.