NCT01665014

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

3.3 years

First QC Date

August 11, 2012

Last Update Submit

August 16, 2012

Conditions

Multiple Myeloma

Keywords

autologous hematopoietic stem cell transplantationtotal marrow irradiationmelphalanmultiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    three years

Secondary Outcomes (1)

  • Rate of complete and very good partial responses

    six months

Other Outcomes (1)

  • Rate of severe adverse events

    one year

Study Arms (1)

Total marrow irradiation

EXPERIMENTAL

Double autologous hematopoietic stem cell transplantation using TMI and HD-Mel

Radiation: Total marrow irradiation

Interventions

Total marrow irradiationRADIATION

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)

Total marrow irradiation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Diagnosis of multiple myeloma
  • Performance status WHO 0-1
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch

Gliwice, 44-101, Poland

Location

Related Publications (1)

  • 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.

    PMID: 21047977BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Sebastian Giebel, MD

    Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Giebel, MD

CONTACT

0048322788523sgiebel@io.gliwice.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations

PL(1)