Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple Myeloma

Phase 1

• Conditions: Multiple Myeloma Stage II or III according to Salmon and Durie; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-004928-21-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: 2008-03-28
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

•Multiple Myeloma Stage II or III according to Salmon and Durie (see Protocol Appendix ?30.5 on page 75)
•Patient's age: 18 – 60 years.
•Patient's written informed consent.
•Compliance with Thalidomide Pregnancy Prevention Plan for Subjects in Clinical Trials” (see Protocol Appendix 30.14 on page 118); becoming effective with protocol version August 27, 2015.
•A maximum of eight chemotherapy cycles prior to registration (CR / PR / MR / or PD).(Melphalan containing regimen should be avoided as induction therapy)

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 220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•More than eight chemotherapy cycles prior to registration.
•Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
•Total bilirubin, SGPT or SGOT > 3 times upper the normal level.
•Left ventricular ejection fraction < 30 %.
•Creatinine clearance < 30 ml/min.
•DLCO < 35 % and/or receiving supplementary continuous oxygen.
•Positive serology for HIV.
•Pregnant or lactating women.
•Participation in another trial at time of registration.
•No HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one mismatch allowed).
•Preceding autologous stem cell transplantation.
•Age > 61 years.

Study & Design

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