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

University of Wuerzburg

Status and phase: Unknown; Phase 3

Conditions: Multiple Myeloma

Treatments: Biological: allogeneic stem cell transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00546988

DSMM V

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 4 patient groups

Standard risk IFN

No Intervention group

Description:

Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation

Standard risk PEGIFN

No Intervention group

Description:

Maintenance treatment with pegylated interferon following autologous stem cell transplantation

High risk allo

Experimental group

Description:

Allogeneic stem cell transplantation from an HLA identical related or unrelated donor

Treatment:

Biological: allogeneic stem cell transplant

High risk auto

No Intervention group

Description:

Second cycle of high-dose melphalan in subjects without an HLA-identical donor