se of a novel chemotherapeutic regimen in an attempt to eradicate residual myeloma disease after a first autologous stem cell Transplantation.

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004778-16-AT
• Lead Sponsor: Department of Medicine I, Ordensklinikum Linz, Elisabethinen Hospital Linz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-19
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

- Anteceding therapeutic sequence of 4 to 6 cycles of an induction therapy followed by a treatment with high-dose melphalan (HD-MEL) and ASCT
- = partial response before HD-MEL
- = very good partial response and MRD-positivity after ASCT

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 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

One or more of the following ultra-high risk features at first diagnosis:
- A Revised International Staging System (R-ISS) score (Palumbo 2015) of III at first diagnosis
- Extended extramedullary disease (especially CNS involvement)
- Plasma cell leukemia

Study & Design

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