MedDataX Logo

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

NCT ID: NCT01665014

Last Updated: 2012-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

autologous hematopoietic stem cell transplantation total marrow irradiation melphalan multiple myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Total marrow irradiation

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

Group Type EXPERIMENTAL

Total marrow irradiation

Intervention Type RADIATION

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebastian Giebel, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Gliwice, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sebastian Giebel, MD

Role: CONTACT

Phone: 0048322788523

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sebastian Giebel, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21047977 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TMI MM1

Identifier Type: -

Identifier Source: org_study_id