Dose Escalation Study of JNJ-54767414 (Daratumumab) in Chinese Participants With Relapsed or Refractory Multiple Myeloma Who Failed at Least 2 Prior Lines of Systemic Therapy
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
Part 1 and 2:
- Chinese participant who must be at least 20 years of age
- Documented multiple myeloma (MM) with measurable disease according to protocol-defined criteria
- Relapsed or refractory multiple myeloma after receiving at least 2 prior lines of therapy
- Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
- Adequate recovery from prior therapy
Part 3:
- Chinese participants who must be at least 18 years of age
- Received both a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months)
- Documented evidence of progressive disease (PD) based on investigator's determination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
Exclusion Criteria:
Part 1 and 2:
- Received daratumumab or other anti-CD38 therapies previously
- Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
- Known chronic obstructive pulmonary disease, known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
- Known clinically significant cardiac disease
- Known to be seropositive for human immunodeficiency virus, hepatitis B or known to have a history of hepatitis C
- Has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
- Abnormal laboratory values according to protocol-defined parameters at screening
Part 3:
- Received anti-myeloma treatment within 2 weeks before Cycle 1, Day 1
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part 1: Dose Escalation Part
Part 2: Pharmacokinetic (PK) Expansion Part
Part 3: Safety Expansion Part
Participants will receive single dose of daratumumab from Week 1 till Week 3 (Period 1 - single dosing period) followed by 6 weekly doses of daratumumab until Week 9 (Period 2 - weekly dosing period) and every 2 weeks for 8 infusions and then once every 4 weeks from Week 26 until disease progression, intolerability, or other reasons for treatment discontinuation (Period 3 - less intense dosing period). A dose of 8 milligram per kilogram (mg/kg) will be chosen as the starting dose and will be escalated to 16 mg/kg if the 8 mg/kg is determined safe and tolerated by study evaluation team (SET).
Participants will receive daratumumab at 16 mg/kg in 3 periods as given in the Part 1.
Participants will receive daratumumab 16 mg/kg every week for 8 weeks followed by every 2 weeks for an additional 16 weeks, and then every 4 weeks thereafter. Participants will be treated with daratumumab until disease progression, intolerability, or any other reasons for treatment discontinuation.