Study Results
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.
COMPLETED
PHASE2
357 participants
INTERVENTIONAL
2001-09-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma
NCT03127761
Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma
NCT01440556
Autologous Transplantation for Multiple Myeloma
NCT00378222
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
NCT00702247
Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
NCT00327314
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
auto/RICallo treatment arm
Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108)
HLA Matched allogeneic transplant
auto arm
patients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104)
HLA Matched allogeneic transplant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HLA Matched allogeneic transplant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age under 70 years
* Life expectancy over 3 months
* Patients must be able to give informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Society for Blood and Marrow Transplantation
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bo Björkstrand, MD
Role: STUDY_CHAIR
Huddinge University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Universität Wien
Vienna, , Austria
Québec, , Canada
Rigshospitalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University
Turku, , Finland
CHU Lapeyronie
Montpellier, , France
University of Heidelberg
Heidelberg, , Germany
University of Leipzig
Leipzig, , Germany
Ospedale Ferrarotto
Catania, , Italy
Ospedale di Careggi
Florence, , Italy
University of Milano
Milan, , Italy
Uni. Modena, Policlinico
Modena, , Italy
IRCCS, Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Rikshospitalet
Oslo, , Norway
Tromsø, , Norway
Trondheim, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Huddinge University Hospital
Huddinge, , Sweden
Stockholm, , Sweden
University Hospital
Uppsala, , Sweden
University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Royal Marsden Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor's website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NMAM2000
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.