ID

23243

Description

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

Keywords

Versions (1)
  1. 6/30/17 6/30/17 -
Uploaded on

June 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma DRKS00003145 NCT01421186 DRKS00003145

English

Eligibility Multiple Myeloma NCT01421186 DRKS00003145

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Male or female subjects 18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Refractory multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0278620
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
Description

M-Protein

Data type

boolean

Alias
UMLS CUI [1]
C0700271
4. Absolute neutrophil count (ANC) ≥ 1,000 / mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
5. Haemoglobin ≥ 8 g/dL
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
6. Ability to comply with all study related procedures, medication use and evaluations
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
1. Primary refractory multiple myeloma
Description

Primary refractory multiple myeloma

Data type

boolean

Alias
UMLS CUI [1,1]
C2347678
UMLS CUI [1,2]
C0026764
2. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
Description

Cerebrovascular disease, Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0442874
3. Treatment with systemic investigational agent within 28 days prior to first study treatment
Description

Prior Treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514463
4. Solitary plasmacytoma or plasma cell leukaemia
Description

Solitary Tumor

Data type

boolean

Alias
UMLS CUI [1]
C0272256
5. Previous allogenic SCT
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
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
Description

Monoclonal Antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0003250
7. Active systemic infection
Description

Active systemic infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
8. Systemic disease preventing study treatment
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
9. Multiple myeloma with CNS involvement
Description

Multiple myeloma with CNS involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0026764
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)
Description

Prior Chemotherapy or Radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
11. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
Description

NYHA

Data type

boolean

Alias
UMLS CUI [1]
C1275491
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Similar models

Eligibility Multiple Myeloma NCT01421186 DRKS00003145

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (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])
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])
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])
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])
NYHA
Item
11. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
boolean
C1275491 (UMLS CUI [1])
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