BridgeMD
Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressed patients with multiple myeloma after first-line therapy (AlloRelapseMMStudy)
EU CTIS ID: 2024-510590-14-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients eligible for study inclusion/enrollment must meet criteria 1-7 and all of the criteria (1-9) before randomization
- 9) CR/ PR or SD according to IMWG criteria after 3 cycles salvage therapy within the study
- 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
You likely can't join if
- Patients are not included in the study if any one of criteria 1-6 are met 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 times higher than normal values Cardiac ejection fraction ≤ 50 % GFR < 30 ml/min DLCO < 35 % 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 study inclusion/enrollment
See the full eligibility criteria
- Patients eligible for study inclusion/enrollment must meet criteria 1-7 and all of the criteria (1-9) before randomization
- 9) CR/ PR or SD according to IMWG criteria after 3 cycles salvage therapy within the study
- 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-CRAB-criteria
- 6) Negative pregnancy test in female patients
- 7) Maximum of 1 cycle salvage therapy prior to study inclusion/enrollment
- 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
- Patients are not included in the study if any one of criteria 1-6 are met 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 times higher than normal values Cardiac ejection fraction ≤ 50 % GFR < 30 ml/min DLCO < 35 % 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 study inclusion/enrollment
- 6. Positive serum pregnancy test at screening and before first treatment or breastfeeding
- 7. Progressive disease (PD) on salvage therapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.