Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma (NCT03477539) | Clinical Trial Compass
CompletedPhase 2
Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma
United States49 participantsStarted 2018-04-09
Plain-language summary
This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Considered transplant eligible
* Pathologically confirmed diagnosis of multiple myeloma who are transplant eligible and have received any prior induction therapy (with or without maintenance)
* Measurable MRD in bone marrow within 28 days prior to registration (MPF method)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 at registration
* Absolute neutrophil count (ANC) \>= 1,000 cell/mm\^3 without growth factor support, obtained =\< 14 days prior to registration
* Platelets \>= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis \< 50% or \>= 30,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of \>= 50%, obtained =\< 14 days prior to registration
* Calculated or measured creatinine clearance \>= 30 ml/min, obtained =\< 14 days prior to registration
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =\< 1.5 X ULN, obtained =\< 14 days prior to registration
* Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) =\< 3 x ULN, obtained =\< 14 days prior to registration
* Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 X ULN, obtained =\< 14 days prior to registration
* Negative urine or serum pregnancy test for women of childbearing potential
* NOTE: females of reproductive potential must adh…
What they're measuring
1
Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT)