Informações:
Falhas:
ID
23243
Descrição
Responsible Party: MorphoSys AG ClinicalTrials.gov Identifier: NCT01421186 History of Changes Other Study ID Numbers: MOR202C101 DRKS00003145 ( Registry Identifier: German Clinical Trail Register ) Study First Received: July 29, 2011 Last Updated: March 21, 2017 A Phase I/IIa Study of Human Anti-CD38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01421186
Link
https://clinicaltrials.gov/ct2/show/NCT01421186
Palavras-chave
Versões (1)
- 30/06/2017 30/06/2017 -
Transferido a
30 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Multiple Myeloma DRKS00003145 NCT01421186 DRKS00003145
Eligibility Multiple Myeloma NCT01421186 DRKS00003145
- StudyEvent: ODM
Similar models
Eligibility Multiple Myeloma NCT01421186 DRKS00003145
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
1. Male or female subjects 18 years and older
boolean
C0001779 (UMLS CUI [1])
Refractory multiple myeloma
Item
Relapsed or refractory multiple myeloma defined as: Parts A, B and C: (i) Failure of at least 2 previous therapies which must have included an immunomodulatory agent and a proteasome inhibitor (either together or part of different therapies) (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma Part D: (i) At least 2 previous therapies including lenalidomide and a proteasome inhibitor (ii) All subjects must have documented progression during or within 60 days after their last prior therapy for multiple myeloma Part E: (i) Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
boolean
C0278620 (UMLS CUI [1])
M-Protein
Item
3. Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg per 24-hour period
boolean
C0700271 (UMLS CUI [1])
Absolute neutrophil count
Item
4. Absolute neutrophil count (ANC) ≥ 1,000 / mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
5. Haemoglobin ≥ 8 g/dL
boolean
C0019046 (UMLS CUI [1])
Compliance
Item
6. Ability to comply with all study related procedures, medication use and evaluations
boolean
C1321605 (UMLS CUI [1])
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Primary refractory multiple myeloma
Item
1. Primary refractory multiple myeloma
boolean
C2347678 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,2])
Cerebrovascular disease, Neuropathy
Item
2. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
boolean
C0007820 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
C0442874 (UMLS CUI [2])
Prior Treatment
Item
3. Treatment with systemic investigational agent within 28 days prior to first study treatment
boolean
C1514463 (UMLS CUI [1])
Solitary Tumor
Item
4. Solitary plasmacytoma or plasma cell leukaemia
boolean
C0272256 (UMLS CUI [1])
Hypersensitivity
Item
5. Previous allogenic SCT
boolean
C0020517 (UMLS CUI [1])
Monoclonal Antibodies
Item
6. Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy with other IgG monoclonal antibodies within 3 months prior to first study treatment, or IgM monoclonal antibodies within 1 month prior to first study treatment
boolean
C0003250 (UMLS CUI [1])
Active systemic infection
Item
7. Active systemic infection
boolean
C0009450 (UMLS CUI [1])
Comorbidity
Item
8. Systemic disease preventing study treatment
boolean
C0009488 (UMLS CUI [1])
Multiple myeloma with CNS involvement
Item
9. Multiple myeloma with CNS involvement
boolean
C4050309 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,2])
Prior Chemotherapy or Radiotherapy
Item
10. Previous treatment with cytotoxic chemotherapy or large field radiotherapy or other myeloma specific therapy within 28 days prior to first study treatment (radiation to a single site as concurrent therapy is allowed)
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C0279134 (UMLS CUI [2])
NYHA
Item
11. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
boolean
C1275491 (UMLS CUI [1])