Stem Cell Translpantation in Multiple Myeloma

Sponsor

European Society for Blood and Marrow Transplantation (Other)

Overall Status

Completed

CT.gov ID

NCT05082675

Collaborator

(none)

260

Enrollment

Locations

124

Duration (Months)

10.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Procedure: HLA Matched allogeneic transplant	Phase 2

Detailed Description

This trial includes a natural (no available HLA-identical sibling donor) control arm. Patients with newly diagnosed multiple myeloma without a sibling are initially treated with conventional chemotherapy followed by conventional single or double autologous transplant (PBSCT). Data from this group is used as part of the control group.

Eligible patients with one or more sibling are offered to participate in the main trial arm. Those who decline are asked to consider taking part in the control group (autograft only).

Patients consenting to participate in the main study first receive the PBSCT, followed by the HLA-matched non-myeloablative allograft (matched for HLA -A, -B, -C, -DRB1).

All study patients receive four to six cycles of VAD (or alternative regimens specified in protocol) before PBSCT as first line treatment. Study entry starts at the time of starting conditioning for autologous transplantation. The search for an identical sibling donor begins as soon as the patient has consented to participate in the study.

The allograft is performed when the patient has restored their marrow function but no earlier than 3 months following PBSCT.

The aim is to demonstrate a difference in outcome (progression free survival, transplant related mortality, relapse rate, and survival).

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase-II Study Comparing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Following Autologous Transplantation to Autologous Transplantation Alone in Multiple Myeloma

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Outcome Measures

Primary Outcome Measures

Progression free survival [5 years]
Progression free survival

Secondary Outcome Measures

Transplant related mortality [5 years]
Transplant related mortality
Complete hematological and molecular remission rate [5 years]
Complete hematological and molecular remission rate
Relapse rate [5 years]
Relapse rate
Survival [5 years]
Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed Stage-II and III multiple myeloma (According to Durie and Salmon classification)
Age under 70 years
Life expectancy over 3 months
Patients must be able to give informed consent

Exclusion Criteria:

Serious concomitant medical disease which would limit life span or the ability to tolerate chemotherapy
Severe cardiac failure (ejection fraction <40%)
Impairment of renal function at diagnosis is not per se reason for exclusion but patients with severe impaired renal function (GFR <50 ml/min) after initial VAD (or VAD like) induction treatment are excluded
Severe impairment of liver function (bilirubin >2 times upper limit of normal)
Pregnant or lactating women
Other major organ system dysfunction (GI, neurological, psychiatric dysfunction) that impairs tolerance of therapy or prolong hematological recovery

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medizinische Universität Wien	Wien	Austria	1090
2		Quebec	Canada
3	Rigshospitalet	Copenhagen	Denmark	2100
4	Herlev Hospital	Herlev	Denmark	2730
5	Helsinki University Central Hospital	Helsinki	Finland	00029
6	Tampere University Hospital	Tampere	Finland	33521
7	Turku University	Turku	Finland	52 20521
8	CHU Lapeyronie	Montpellier	France	34295
9	University of Heidelberg	Heidelberg	Germany	69120
10	University of Leipzig	Leipzig	Germany	04103
11	Ospedale Ferrarotto	Catania	Italy	95100
12	Ospedale di Careggi	Florence	Italy	50134
13	University of Milano	Milano	Italy	20133
14	Uni. Modena, Policlinico	Modena	Italy	41100
15	IRCCS, Casa Sollievo della Sofferenza	San Giovanni Rotondo	Italy	71013
16	Rikshospitalet	Oslo	Norway	0027
17		Tromso	Norway
18		Trondheim	Norway
19	Sahlgrenska University Hospital	Gothenburg	Sweden	413 45
20	Huddinge University Hospital	Huddinge	Sweden	141 86
21		Stockholm	Sweden
22	University Hospital	Uppsala	Sweden	75185
23	University Faculty of Medicine	Ankara	Turkey	06260
24	Royal Marsden Hospital	London	United Kingdom	SM2 5PT