Clinical trial NCT05082675: Stem Cell Translpantation in Multiple Myeloma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: myeloma
HLA-matched
autologous
allogeneic
transplant
Lead sponsor: European Society for Blood and Marrow Transplantation
Sponsor class: NETWORK
First posted: 2021-10-19
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) and patients without a matched sibling donor were allocated to the auto arm (n = 249)
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
measure: Transplant related mortality
timeFrame: 5 years
measure: Complete hematological and molecular remission rate
timeFrame: 5 years
measure: Relapse rate
timeFrame: 5 years
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Quebec
country: Canada
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Leipzig
country: Germany
facility: University of Leipzig
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Florence
country: Italy
facility: Ospedale di Careggi
city: Milano
country: Italy
facility: University of Milano
city: Modena
country: Italy
facility: Uni. Modena, Policlinico
city: San Giovanni Rotondo
country: Italy
facility: IRCCS, Casa Sollievo della Sofferenza
city: Oslo
country: Norway
facility: Rikshospitalet
city: Tromso
country: Norway
city: Trondheim
country: Norway
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Huddinge
country: Sweden
facility: Huddinge University Hospital
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
facility: University Hospital
city: Ankara
country: Turkey
facility: University Faculty of Medicine
city: London
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Huddinge University Hospital
name: Bo Björkstrand, MD
role: STUDY_CHAIR
References: