NCT05082675

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_2 multiple-myeloma

Geographic Reach
11 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
Last Updated

September 11, 2023

Status Verified

October 1, 2021

Enrollment Period

9.3 years

First QC Date

September 21, 2021

Last Update Submit

September 7, 2023

Conditions

Multiple Myeloma

Keywords

myelomaHLA-matchedautologousallogeneictransplant

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    Progression free survival

    5 years

Secondary Outcomes (4)

  • Transplant related mortality

    5 years

  • Complete hematological and molecular remission rate

    5 years

  • Relapse rate

    5 years

  • Survival

    5 years

Study Arms (2)

auto/RICallo treatment arm

EXPERIMENTAL

Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108)

Procedure: HLA Matched allogeneic transplant

auto arm

ACTIVE COMPARATOR

patients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104)

Procedure: HLA Matched allogeneic transplant

Interventions

HLA Matched allogeneic transplantPROCEDURE
auto armauto/RICallo treatment arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Serious concomitant medical disease which would limit life span or the ability to tolerate chemotherapy
  • Severe cardiac failure (ejection fraction \<40%)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Unknown Facility

Québec, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University

Turku, 52 20521, Finland

Location

CHU Lapeyronie

Montpellier, 34295, France

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

University of Leipzig

Leipzig, 04103, Germany

Location

Ospedale Ferrarotto

Catania, 95100, Italy

Location

Ospedale di Careggi

Florence, 50134, Italy

Location

University of Milano

Milan, 20133, Italy

Location

Uni. Modena, Policlinico

Modena, 41100, Italy

Location

IRCCS, Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Rikshospitalet

Oslo, 0027, Norway

Location

Unknown Facility

Tromsø, Norway

Location

Unknown Facility

Trondheim, Norway

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Huddinge University Hospital

Huddinge, 141 86, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

University Hospital

Uppsala, 75185, Sweden

Location

University Faculty of Medicine

Ankara, 06260, Turkey (Türkiye)

Location

Royal Marsden Hospital

London, SM2 5PT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bo Björkstrand, MD

    Huddinge University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

October 19, 2021

Study Start

September 1, 2001

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

September 11, 2023

Record last verified: 2021-10

Locations

NO(3)AU(1)DE(2)TU(1)GB(1)DK(2)FI(3)SE(4)FR(1)CA(1)IT(5)