Overview

Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy

Status:
Not yet recruiting

Trial end date:
2028-05-01

Target enrollment:
0

Participant gender:
All

Summary

Allogeneic stem cell (allo SCT) transplantation for multiple myeloma is a potential curative treatment, but is associated with morbidity and treatment related mortality. Approved drug combinations or another autologous stem cell transplantation (auto-SCT) can be used for relapsed patients resulting in a median progression free survival up to 2-3 years. In the current trial after first-line treatment relapsed or progressed myeloma patients with an HLA compatible donor will be randomized after 3 cycles of salvage therapy to allogeneic stem cell transplantation or to continuous conventional salvage therapy.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Collaborators:

Gemeinsamer Bundesausschuss (G-BA)
Staburo GmbH

Treatments:

Antibodies, Monoclonal
BB 1101
Bortezomib
Daratumumab
Dexamethasone
Dexamethasone acetate
Elotuzumab
Ixazomib
Lenalidomide
Pomalidomide

Criteria

Inclusion Criteria:

Patients eligible for study inclusion must meet criteria 1- 7 at registration and all of
the following criteria before randomization:

1. Multiple Myeloma

2. Age 18 - 65 years

3. A signed informed consent form must be obtained before participation in the study

4. Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1

5. 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 criteria

6. Negative pregnancy test in female patients

7. Maximum of 1 cycle salvage therapy prior to study inclusion

8. 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

9. CR/PR or SD according to IMWG-criteria after 3 cycles salvage therapy within the study

Exclusion Criteria:

Patients are excluded from the study if any one of criteria 1-6 are met at registration and
if criterion 7 is met before randomization:

1. Non-sufficient organ function defined as:

Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥3 higher than
normal values Cardiac ejection fraction ≤ 50% GFR < 30 ml/min DLCO < 50% and/or
continuous oxygen dependency

2. Active hepatitis B or C infection or uncontrolled HIV infection

3. Other, active malignant disease

4. Prior treatment with allogeneic stem cells

5. 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 registration

6. Positive serum pregnancy test at screening and before first treatment or breastfeeding

7. PD under salvage therapy