Phase
Condition
Multiple Myeloma
Bone Neoplasm
Lymphoproliferative Disorders
Treatment
OPN-6602
Dexamethasone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed diagnosis of multiple myeloma (MM)
Relapsed or refractory to 3 or more different prior lines of therapy for MM thatincluded immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody andnot a candidate for or intolerant to established therapy known to provide clinicalbenefit
Adequate hematologic, renal, liver, cardiac function
Exclusion
Exclusion Criteria:
Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma,Waldenström's macroglobulinemia, or IgM myeloma
Active plasma cell leukemia
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
Prior Stevens Johnson syndrome
Localized radiation therapy to disease site(s) within 2 weeks of the first dose
Prior autologous peripheral stem cell transplant or prior autologous bone marrowtransplantation within <90 days of the first dose of study drug
Prior allogeneic stem cell transplantation or solid organ transplantation within 12months of screening; subjects receiving immunosuppressive medication for activegraft vs host disease will be excluded.
Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior tofirst dose of study drug
Concomitant high-dose corticosteroids (except subjects on chronic steroids given fordisorders other than myeloma)
Known central nervous system involvement by multiple myeloma
Active known second malignancy with exception of adequately treated basal cellcarcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer;adequately treated Stage 1 cancer from which the subject is currently in remissionand has been in remission for ≥2 years; low-risk prostate cancer with a Gleasonscore <7 and a PSA level <10 ng/mL; any other cancer from which the subject has beendisease-free for ≥3 years
Ongoing systemic infection requiring parenteral treatment
Poorly controlled Type 2 diabetes
Study Design
Connect with a study center
Banner MD Anderson
Gilbert, Arizona 85234
United StatesActive - Recruiting
Stanford Cancer Institute
Stanford, California 94305
United StatesActive - Recruiting
Emory Winchip Cancer Center
Atlanta, Georgia 30322
United StatesActive - Recruiting
University of Kansas Clinical Research Center
Westwood, Kansas 66205
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
START Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14642
United StatesActive - Recruiting
Huntsman Cancer Center Institute University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesActive - Recruiting
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