---
title: Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma
nct_id: NCT01665014
overall_status: UNKNOWN
phase: PHASE2
sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
study_type: INTERVENTIONAL
primary_condition: Multiple Myeloma
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01665014.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01665014"
ct_last_update_post_date: 2012-08-17
last_seen_at: "2026-05-12T07:27:03.786Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01665014](https://clinicaltrials.gov/study/NCT01665014)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
- **Conditions:** Multiple Myeloma
- **Start Date:** 2012-08
- **Completion Date:** 2016-08
- **CT.gov Last Update:** 2012-08-17

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Total marrow irradiation** (EXPERIMENTAL) — Double autologous hematopoietic stem cell transplantation using TMI and HD-Mel

## Interventions

- **Total marrow irradiation** (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)

## Primary Outcomes

- **Progression-free survival** _(time frame: three years)_

## Secondary Outcomes

- **Rate of complete and very good partial responses** _(time frame: six months)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `locations.maria sklodowska-curie memorial cancer center and institute of oncology, gliwice branch|gliwice||poland` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01665014.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01665014*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*