Description:

Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02289222

Link:

https://clinicaltrials.gov/show/NCT02289222

Keywords:
Versions (1) ▾
  1. 5/13/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

May 13, 2019

DOI:
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License:
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02289222

Eligibility Multiple Myeloma NCT02289222

Inclusion Criteria
1. confirmed diagnosis of relapsed and/or refractory mm according to international myeloma working group guidelines (2003)
2. documented disease progression during or within 60 days after their most recent line of anti-myeloma therapy.
3. failure of 2 lines of prior therapy that includes an imid (lenalidomide or thalidomide) and a proteasome inhibitor (bortezomib and/or carfilzomib) (used either separately or in combination).
4. measurable disease as defined by the protocol.
5. be willing and able to provide written informed consent/assent for the trial.
6. have a performance status of 0 1 2 on the ecog performance scale.
7. demonstrate adequate organ function as defined by the protocol.
8. female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.
9. male subjects should agree to use an adequate method of contraception.
Exclusion Criteria
1. is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
2. has a diagnosis of immunodeficiency (hiv) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
3. has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
4. has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. (subjects with
≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.)
5. has a known additional malignancy that is progressing or requires active treatment.
6. has known active central nervous system disease and/or carcinomatous meningitis.
7. has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
8. has evidence of interstitial lung disease or active, non-infectious pneumonitis.
9. has an active infection requiring systemic therapy.
10. has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.