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Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma

This study is not yet open for participant recruitment.
Verified August 2012 by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
ClinicalTrials.gov Identifier:
NCT01665014
First received: August 11, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Multiple Myeloma
 Radiation: Total marrow irradiation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complete and very good partial responses [ Time Frame: six months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Rate of severe adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total marrow irradiation
Double autologous hematopoietic stem cell transplantation using TMI and HD-Mel
 Radiation: Total marrow irradiation
Mobilization of stem cells with the use of cytarabine 1.6 g/m2 followed by filgrastim 480 ug/d. Conditioning for the 1st autoHSCT: total marrow irradiation 4 Gy on days -3,-2,-1 (total 12 Gy). Conditioning for 2nd autoHSCT performed 3-4 months after the 1st one: melphalan 100 mg/m2 on days -2,-3 (total 200 mg/m2)

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665014

Contacts
Contact: Sebastian Giebel, MD 0048322788523 sgiebel@io.gliwice.pl

Locations
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch Not yet recruiting
Gliwice, Poland, 44-101
Contact: Sebastian Giebel, MD     0048322788523     sgiebel@io.gliwice.pl    
Principal Investigator: Sebastian Giebel, MD            
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Investigators
Principal Investigator: Sebastian Giebel, MD Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
  More Information

Publications:

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
ClinicalTrials.gov Identifier: NCT01665014     History of Changes
Other Study ID Numbers: TMI MM1
Study First Received: August 11, 2012
Last Updated: August 16, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice:
autologous hematopoietic stem cell transplantation
total marrow irradiation
melphalan
multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013