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ID

44159

Description

ODM derived from http://clinicaltrials.gov/show/NCT00478777

Link

http://clinicaltrials.gov/show/NCT00478777

Keywords

Clinical Trial

Multiple Myeloma

Eligibility Determination

Versions (4)

12/11/13 12/11/13 - Martin Dugas
4/14/14 4/14/14 - Julian Varghese
4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
9/20/21 9/20/21 -

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility DRKS00003823 NCT00478777 Relapsed or Refractory Multiple Myeloma

English 2

German English

Details

Eligibility

1 forms

StudyEvent: Eligibility
1. Eligibility

Inclusion Criteria

age at least 18

Yes

Must understand and voluntarily sign an informed consent form.

Yes

Must be >=18 years of age at the time of signing the informed consent form.

Yes

Must be able to adhere to the study visit schedule and other protocol requirements.

Yes

Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.

Yes

Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.

Yes

Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).

Yes

Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample).

Yes

ECOG performance status <= 2

Yes

Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug 2) while participating in the study and 3) for at least 28 days after discontinuation from the study.

Yes

Exclusion Criteria

The presence of any of the following will exclude a subject from study enrollment:

Yes

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

Yes

Pregnant or lactating females.

Yes

Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

Yes

Any of the following laboratory abnormalities:

Yes

Absolute Neutrophil Count

Yes

Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.

Yes

Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.

Yes

Serum Creatinine Measurement

Yes

Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)

Yes

Serum Total Bilirubin Measurement

Yes

Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >=1 year.

Yes

Prior history of stroke and/or thromboembolic event

Yes

Known hypersensitivity to thalidomide or dexamethasone.

Yes

Prior history of uncontrollable side effects to dexamethasone therapy.

Yes

The development of a desquamating rash while taking thalidomide.

Yes

Neuropathy >= Grade 2.

Yes

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