Mode
Text Size
Log in / Sign up
Phase 3 N=522 Randomized Treatment

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

Enrolled (actual)
522
Serious AEs
33.2%
Results posted
Jul 2020
Primary outcome: Primary: Overall Response Rate (ORR) — 39.4; 43.3 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Dara SC (Drug); Dara IV (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Janssen Research & Development, LLC
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate (ORR)
39.4; 43.3
PRIMARY
Maximum Trough Concentration (Ctrough) of Daratumumab
525; 611
SECONDARY
Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
34.5; 12.7
SECONDARY
Progression Free Survival (PFS)
6.08; 5.62
SECONDARY
Percentage of Participants With Very Good Partial Response (VGPR) or Better
21.6; 23.6
SECONDARY
Percentage of Participants With Complete Response (Including sCR) or Better
5.4; 4.6
SECONDARY
Time to Next Therapy
9.43; 8.80
SECONDARY
Overall Survival (OS)
25.56; 28.19
SECONDARY
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
70.5; 76.9; 72.1; 78.8; 72.8; 78.7
SECONDARY
Duration of Response
10.64; 10.15
SECONDARY
Time to Partial Response (PR) or Better
1.02; 1.02
SECONDARY
Time to Very Good Partial Response (VGPR) or Better
1.92; 1.95
SECONDARY
Time to Complete Response (CR) or Better
7.23; 9.26

Summary

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

Eligibility Criteria

Inclusion Criteria

  • Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
  • Received at least 3 prior lines of therapy including 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). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy
  • Documented multiple myeloma as defined by the criteria below:
  • Multiple myeloma diagnosis according to the IMWG diagnostic criteria
  • Measurable disease at Screening as defined by any of the following:
  • Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
  • Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Meet the clinical laboratory criteria as specified in the protocol
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

Exclusion Criteria

  • Received daratumumab or other anti-CD38 therapies previously
  • Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
  • Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
  • Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
  • History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further 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 3 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03277105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search