Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years

Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00546988

Enrollment

600

Registered

2007-10-19

Start date

2001-10-31

Completion date

2008-01-31

Last updated

2007-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

primary treatment, allogeneic stem-cell transplantation, high-dose therapy, cytogenetics

Brief summary

The study is evaluating whether risk-stratification by the means of a chromosomal aberration provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor available.

Detailed description

The DSMM V protocol is to compare a consolidation treatment for standard-risk patients not displaying del(13) at initial diagnosis following two cycles of high-dose melphalan 200 mg/m² each supported by autologous stem cell retransfusion with interferon versus PEG-interferon. Patients with del(13) are screened for availability of a fully HLA-matched related or unrelated donor. If patient's informed consent is obtained additionally, he is scheduled to undergo an allogeneic SCT following the first cycle of high-dose melphalan. All other subjects are to proceed to a second course of high-dose melphalan similar to the standard-risk group. Initial cytoreduction is foreseen with four cycles of anthracycline-dexamethasone combination followed by combination therapy with ifosfamide/epirubicine/etoposide for stem-cell collection.

Interventions

BIOLOGICALallogeneic stem cell transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Primary diagnosis of multiple myeloma * Salmon-and-Durie stage II or III * Less than or equal to 60 years * Signed informed consent

Exclusion criteria

* Relevant comorbidities * Unable to adhere to study protocol * Pregnancy * Not received subject's informed consent

Design outcomes

Primary

Measure	Time frame
Response rate after high-dose therapy	one year

Secondary

Measure	Time frame
Response rate and treatment-related mortality after allogeneic transplantation	one year

Countries

Austria, Germany

Contacts

Primary ContactHermann Einsele, M.D.

einsele_h@klinik.uni-wuerzburg.de+49/931/201-0

Backup ContactStefan Knop, M.D.

knop_s@klinik.uni-wuerzburg.de+49/931/201-0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026