SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Daratumumab is human immunoglobulin G1 kappa monoclonal antibody (IgG1k) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up period (after end of treatment and up to 16 weeks after last dose. Topical Ibuprofen for Delayed Onset Mulscle Soreness. Talquetamab binds to cluster of differentiation 3 (CD3) receptor complex on T cells and to G protein-coupled receptor family C group 5-member D (GPRC5D), a 7-transmembrane receptor protein on plasma cells and teclistamab binds to human and cynomolgus-CD3 and B cell maturation antigen (BCMA). Study of Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma NCT01578967 SET consists of members of sponsor's study team and participating investigators.Participants will be assigned to either a combination of daratumumab plus teclistamab or daratumumab plus talquetamab in 28-day cycles (weekly in Cycles 1-2, every 2 weeks (Q2W) in Cycles 3-6, and every 4 weeks thereafter) once weekly in 28 day cycles, in a step-up dosing fashion in Cycle 1 until the treatment dose is reached, to establish the recommended Phase 2 dose(s) RP2D(s) of each treatment combination.Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1 until disease progression, unacceptable toxicity, withdrawal of consent, otherwise deemed necessary by the investigator or the sponsor, or end of study.The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 daystime weighted Sum of Muscle Soreness with Movement (change from baseline) over 0-24 hours post Dose 1 (SMSM0-24)Change from baseline in the time weighted sum of muscle soreness with movement over 24-48 hours, 48-72 hours, and 0-72 hours, and the change from baseline in muscle soreness with movement at each assessment time pointChange from baseline in the time weighted sum of spontaneous muscle soreness over 0-24 hours, 24-48 hours, 48-72 hours, and 0-72 hours and the change from baseline in spontaneous muscle soreness at each assessment time pointTime weighted sum of muscle soreness relief over 0-24 hours, 24-48 hours, 48-72 hours, and 0-72 hours and the relief score at each assessment time pointChange from baseline in muscle stiffness at 24 hours Total duration of study is approximately 2.4 years.
Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the studyUse of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma - Full Text View.
Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the studyUse of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma - Full Text View.