Microdose Study of Melphalan, Bortezomib and Dexamethasone (Phase-0-MM)

Henrik Gregersen

Status and phase: Unknown; Early Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Melphalan; Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT02109861

KFE2011.06

2011-003791-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. Blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned treatment for Multiple Myeloma (newly diagnosed as well as relapse and refractory disease) with one of the following chemotherapy regimens: 1) Highdose melphalan, 2) Bortezomib or 3) Dexamethasone
• 18 years or older.
• Understand and have the will to sign the informed consent.

Exclusion criteria

• Prior treatment with the study drug
• Received treatment with biphosphonates in the week prior to study treatment

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Melphalan

Experimental group

Description:

A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan

Treatment:

Drug: Melphalan

Bortezomib

Experimental group

Description:

A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib

Treatment:

Drug: Bortezomib

Dexamethasone

Experimental group

Description:

A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone

Treatment:

Drug: Dexamethasone