A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Daratumumab; Lenalidomide; Dexamethasone
Intervention description: Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; and every 4 weeks for cycles 7 and onwards. Following amendment 8, participants receiving daratumumab IV have the option to switch to daratumumab subcutaneous (SC) 1800 mg/dose until documented progression, unacceptable toxicity, or the end of study on Day 1 of any cycle, at the discretion of the investigator.; Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.; Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 18.5).
Intervention MeSH terms: Dexamethasone; Lenalidomide; Daratumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 569.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Daratumumab; Lenalidomide; Dexamethasone

Summary:

      The purpose of this study is to compare the effectiveness of daratumumab when combined with
      lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms
      of progression-free survival in participants with relapsed or refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have documented multiple myeloma and measurable disease

          -  Must have received at least 1 prior line of therapy for multiple myeloma and achieved
             a response (partial response or better) to at least one prior regimen

          -  Must have documented evidence of progressive disease as defined by the International
             Myeloma Working Group criteria on or after their last regimen

          -  Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2

          -  If a participant has received subsequent anticancer therapy (salvage therapy), the
             participant must have a "wash-out period" defined as 2 weeks or 5 pharmacokinetic
             half-lives of the treatment, whichever is longer, before the planned start date of
             daratumumab monotherapy. The only exception is the emergency use of a short course of
             corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4
             days) before Daratumumab monotherapy

        Exclusion Criteria:

          -  Has received any of the following therapies: daratumumab or other anti-CD38 therapies

          -  Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of
             the treatment

          -  Disease shows evidence of refractoriness or intolerance to lenalidomide or if
             previously treated with a lenalidomide-containing regimen the participant is excluded
             if he or she discontinued due to any adverse event related to prior lenalidomide
             treatment

          -  Has received autologous stem cell transplantation within 12 weeks before the date of
             randomization, or previously received an allogenic stem cell transplant (regardless of
             timing), or planning to undergo a stem cell transplant prior to progression of disease

          -  History of malignancy (other than multiple myeloma) within 5 years before the first
             dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of
             the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion,
             that in the opinion of the investigator, with concurrence with the sponsor's medical
             monitor, is considered cured with minimal risk of recurrence within 5 years)