Stem Cell Translpantation in Multiple Myeloma

September 7, 2023 updated by: European Society for Blood and Marrow Transplantation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Medizinische Universitat Wien
  • Canada
      • Quebec, Canada
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Herlev, Denmark, 2730
        • Herlev Hospital
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital
      • Tampere, Finland, 33521
        • Tampere University Hospital
      • Turku, Finland, 52 20521
        • Turku University
  • France
      • Montpellier, France, 34295
        • CHU Lapeyronie
  • Germany
      • Heidelberg, Germany, 69120
        • University of Heidelberg
      • Leipzig, Germany, 04103
        • University of Leipzig
  • Italy
      • Catania, Italy, 95100
        • Ospedale Ferrarotto
      • Florence, Italy, 50134
        • Ospedale di Careggi
      • Milano, Italy, 20133
        • University of Milano
      • Modena, Italy, 41100
        • Uni. Modena, Policlinico
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS, Casa Sollievo della Sofferenza
  • Norway
      • Oslo, Norway, 0027
        • Rikshospitalet
      • Tromso, Norway
      • Trondheim, Norway
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Huddinge, Sweden, 141 86
        • Huddinge University Hospital
      • Stockholm, Sweden
      • Uppsala, Sweden, 75185
        • University Hospital
  • Turkey
      • Ankara, Turkey, 06260
        • University Faculty of Medicine
  • United Kingdom
      • London, United Kingdom, SM2 5PT
        • Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: auto/RICallo treatment arm
Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108)
Procedure: HLA Matched allogeneic transplant
Active Comparator: auto arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 5 years
Progression free survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Survival
5 years
Transplant related mortality
Time Frame: 5 years
Transplant related mortality
5 years
Complete hematological and molecular remission rate
Time Frame: 5 years
Complete hematological and molecular remission rate
5 years
Relapse rate
Time Frame: 5 years
Relapse rate
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society for Blood and Marrow Transplantation

Investigators

  • Study Chair: Bo Björkstrand, MD, Huddinge University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMAM2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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