MedPath

A scientific experiment on patients, to evaluate the effects of various treatments used for bonemarrowcancer, on cells and genes.

Phase 1
Conditions
Multiple Myelomatosis (MM).
MedDRA version: 14.1Level: LLTClassification code 10028569Term: Myelomatosis multipleSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2011-003791-37-DK
Lead Sponsor
Department of Haematology, Aalborg University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
21
Inclusion Criteria

Any patient who,
• is set start a planned treatment for Multiple Myelomatosis (Newly diagnosed as well as relaps and refractory disease) with one of the following chemotherapy regimens: Highdose Alkeran (includes melphalan), or VEL-DEX/Velcade therapy alone (includes Bortezomib), or VEL-DEX/Dexaven therapy alone (Includes Dexaven).
• is 18 years or older.
• can understand and have the will to sign the informed consent.
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 21

Exclusion Criteria

Any patient who,
• have their planned treatment cancelled immediately prior to the experiment.
• have received treatment with biphosphonates in the week prior to the experiment.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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