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

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001005-67-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-23
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

Patients eligible for study inclusion must meet criteria 1-6 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)1. Relapsed/progressed after autologous SCT (single or tandem)
First line therapy comprises induction therapy followed by single or tandem autologous transplantation and maintenance therapy
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 434
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

Patients are excluded from the study if any one of criteria 1-4 are met at registration and if criterion 5 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified