Stem Cell Translpantation in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082675
• Other study ID #: NMAM2000
• Status: Completed
• Phase: Phase 2
• Start date: September 2001
• Est. completion date: January 2012

Study information

• Verified date: October 2021
• Source: European Society for Blood and Marrow Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• HLA Matched allogeneic transplant

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien	Wien
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Finland	Helsinki University Central Hospital	Helsinki
Finland	Tampere University Hospital	Tampere
Finland	Turku University	Turku
France	CHU Lapeyronie	Montpellier
Germany	University of Heidelberg	Heidelberg
Germany	University of Leipzig	Leipzig
Italy	Ospedale Ferrarotto	Catania
Italy	Ospedale di Careggi	Florence
Italy	University of Milano	Milano
Italy	Uni. Modena, Policlinico	Modena
Italy	IRCCS, Casa Sollievo della Sofferenza	San Giovanni Rotondo
Norway	Rikshospitalet	Oslo
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Huddinge University Hospital	Huddinge
Sweden	University Hospital	Uppsala
Turkey	University Faculty of Medicine	Ankara
United Kingdom	Royal Marsden Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
European Society for Blood and Marrow Transplantation

Countries where clinical trial is conducted

Austria,  Canada,  Denmark,  Finland,  France,  Germany,  Italy,  Norway,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Progression free survival	5 years
Secondary	Transplant related mortality	Transplant related mortality	5 years
Secondary	Complete hematological and molecular remission rate	Complete hematological and molecular remission rate	5 years
Secondary	Relapse rate	Relapse rate	5 years
Secondary	Survival	Survival	5 years

External Links

•   Sponsor's website