Skip to main content
MedPathMedPath Home
Clinical Trials/2024-510590-14-00
2024-510590-14-00
Completed
Phase 3

Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressive patients with multiple myeloma after a first-line therapy

University Medical Center Hamburg-Eppendorf30 sites in 1 country400 target enrollmentStarted: September 2, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 3
Status
Completed
Sponsor
University Medical Center Hamburg-Eppendorf
Enrollment
400
Locations
30
Primary Endpoint
Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The present clinical study aims to demonstrate the superiority of allogeneic stem (alloSCT) cell transplantation compared to conventional therapy for the difference in overall survival (OS) at 5 years in patients with multiple myeloma who have relapsed or progressed after first-line autologous hematopoietic stem cell therapy.

Study Design

Allocation
Randomized
Primary Purpose
Treatment period 2
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients eligible for study inclusion/enrollment must meet criteria 1-7 and all of the criteria (1-9) before randomization
  • •CR/ PR or SD according to IMWG criteria after 3 cycles salvage therapy within the study
  • •Multiple Myeloma
  • •Age 18 - 65 years
  • •A signed informed consent form must be obtained before participation in the study
  • •Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1
  • •1st relapse/ progression according to IMWG criteria after first-line therapy (consisting of induction therapy followed by autologous transplantation once or twice and maintenance therapy) Additionally: meeting the need for treatment based on the SLiM-CRAB-criteria
  • •Negative pregnancy test in female patients
  • •Maximum of 1 cycle salvage therapy prior to study inclusion/enrollment
  • •Availability of a fully compatible stem cell donor (HLA-ident. sibling or 10/10 MUD or 9/10 MMUD if mismatch affects DQB) after 3 cycles salvage therapy

Exclusion Criteria

  • •Patients are not included in the study if any one of criteria 1-6 are met and if criterion 7 is met before randomization:
  • •Non-sufficient organ function defined as:  Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥ 3 times higher than normal values  Cardiac ejection fraction ≤ 50 %  GFR < 30 ml/min  DLCO < 35 % or continuous oxygen dependency
  • •Active hepatitis B or C infection or uncontrolled HIV infection
  • •Other, active malignant disease
  • •Prior treatment with allogeneic stem cells
  • •Participation in a clinical trial or taking an IMP within 30 days or five times the half-life of the IMP, whichever is longer, prior to study inclusion/enrollment
  • •Positive serum pregnancy test at screening and before first treatment or breastfeeding
  • •Progressive disease (PD) on salvage therapy

Outcomes

Primary Outcomes

Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)

Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)

Secondary Outcomes

  • Event-free survival (EFS) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 1 year after randomization). Event defined as:  Progression (according to IMWG criteria) or  Relapse (according to IMWG criteria) or  Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or  Death of any cause
  • Event-free survival at 3 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 3 years after randomization) Event defined as:  Progression (according to IMWG criteria) or  Relapse (according to IMWG criteria) or  Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or  Death of any cause
  • Event-free survival at 5 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 5 years after randomization) Event defined as:  Progression (according to IMWG criteria) or  Relapse (according to IMWG criteria) or  Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or  Death of any cause
  • Change from baseline in total EORTC score at 1 year after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 1 year after randomization)
  • Change from baseline in total EORTC score at 3 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 3 years after randomization)
  • Change from baseline in total EORTC score at 5 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 5 years after randomization)
  • Time to first occurrence of remission (partial or complete) after randomization (Patient is followed from randomization until database lock for final analysis and cumulative incidence of first remission, at 2 years after randomization, is reported)
  • Non-relapse mortality (NRM) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 1 year after randomization reported)
  • Non-relapse mortality (NRM) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 3 years after randomization reported)
  • Non-relapse mortality (NRM) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 5 years after randomization reported)
  • Cumulative incidence of acute graft-versus-host disease (GvHD) after allogeneic stem cell transplantation (according to Przepiorka et al.[1]) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 1year after randomization reported)
  • Cumulative incidence of acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al.[1]) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 3 years after randomization reported
  • Cumulative incidence of acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al. [1]) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 5 years after randomization reported)
  • Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al.[2]) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 1 year after randomization reported)
  • Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [2]) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 3 years after randomization reported)
  • Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [2]) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 5 years after randomization reported)
  • Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 1 year after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 1 year after randomization reported).
  • Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 3 years after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 3 years after randomization reported).
  • Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 5 years after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 5 years after randomization reported).

Investigators

Sponsor
University Medical Center Hamburg-Eppendorf
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Sponsor UKE Hamburg

Scientific

University Medical Center Hamburg-Eppendorf

Study Sites (30)

Loading locations...

Similar Trials

Recruiting
Phase 4
Benefit of transplantation after Complete Response In Patients with T-cell lymphoma
2022-501710-62-02Lysarc204
Recruiting
Phase 2
Phase I/II randomized clinical trial of allogeneic adipose tissue-derived mesenchymal stromal cells systemic infusion in severe systemic sclerosis MSC-AT-SSc
2023-505977-34-00Assistance Publique Hopitaux De Paris18
Completed
Not Applicable
The Oral cGVHD as a Predictive Factor of Graft Versus Leukaemia Effect in Patients Who Received an Allograft
NCT07271498Centre Hospitalier Universitaire de Nice93
Active, not recruiting
Not Applicable
Allogeneic Stem Cell Transplantation in Children and Adolesecents with Acute Lymphoblastic Leukaemia
EUCTR2012-003032-22-FISt. Anna Kinderkrebsforschung1,000
Recruiting
Phase 2
Allogeneic hematopoietic cell transplantation from HLA-matched donor after Flu-Mel-PTCy versus Flu-Mel-ATG reduced-intensity conditioning: a phase II randomized study from the Belgian Hematology Society (BHS)
2024-518568-11-00Centre Hospitalier Universitaire De Liege, Centre Hospitalier Universitaire De Liege114