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Phase 2 Completed N=223 Randomized Treatment

Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

Source: ClinicalTrials.gov NCT02874742 ↗
Enrolled (actual)
223
Serious AEs
51.2%
Results posted
Feb 2020
Primary outcomePrimary: Percentage of Participants With Stringent Complete Response (sCR) — 32.0; 42.4 Percentage of participants

Summary

The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR), as defined by the International Myeloma Working Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Stringent Complete Response (sCR)
32.0; 42.4
SECONDARY
Percentage of Participants With Complete Response (CR) or Better
13.4; 19.2; 12.5; 19.6; 27.3; 56.3
SECONDARY
Percentage of Participants With Overall Stringent Complete Response (sCR)
7.2; 12.1; 0; 14.4; 21.2; 43.8
SECONDARY
Percentage of Participants With Overall Response Rate (ORR)
91.8; 98.0; 100; 91.8; 99.0; 100
SECONDARY
Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better
56.7; 71.7; 68.8; 66.0; 86.9; 100
SECONDARY
Percentage of Participants With Negative Minimal Residual Disease (MRD)
7.8; 22.1; 18.8; 20.4; 50.0; 50.0
SECONDARY
Duration of Complete Response or Better
NA; NA; NA
SECONDARY
Duration of Stringent Complete Response (sCR)
NA; NA; NA
SECONDARY
Time to Stringent Complete Response (sCR)
14.3; 10.2; 8.4
SECONDARY
Time to Complete Response or Better
9.6; 8.9; 7.7
SECONDARY
Time to Very Good Partial Response (VGPR) or Better
3.0; 2.2; 2.1
SECONDARY
Time to Partial Response (PR) or Better
0.8; 0.8; 0.8
SECONDARY
Progression-free Survival (PFS)
NA; NA; NA
SECONDARY
Overall Survival (OS)
NA; NA; NA
SECONDARY
Time to Progression (TTP)
NA; NA; NA
SECONDARY
Duration of Response
NA; NA; NA

Eligibility Criteria

Inclusion Criteria

  • Considered by the investigator to be eligible for high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT) according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory studies
  • Has not had prior systemic therapy for multiple myeloma. An emergency course of steroids (defined as no greater than 40 milligram [mg] of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Woman of childbearing potential must have 2 negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) during screening, the first one within 10 to 14 days prior to the first dose of any component of study treatment and the second within 24 hours prior to the first dose of any component of study treatment
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (including during dose interruptions), and for 4 weeks following discontinuation of lenalidomide, and if receiving daratumumab, for 3 months after the last dose

Exclusion Criteria

  • Diagnosed or treated for malignancy other than multiple myeloma, except: a) Malignancy treated with curative intent and with no known active disease present for more than equal to (>= )3 years before randomization; b) Adequately treated non-melanoma skin cancer, lentigo maligna or in situ malignancies (including but not limited to, cervical, breast) with no evidence of disease
  • Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma
  • Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) less than (<)50 percent (%) of predicted normal
  • Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
  • Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C. Participants who completed treatment for hepatitis C at least 6 months prior to screening and have no detectable circulating hepatitis C virus (HCV) at screening, may participate in the study. Such participants will be required to undergo regular assessment for HCV reactivation during their participation in the study. Participants who test positive for HCV at any time during these assessments will be withdrawn from the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02874742). 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. Informational only — not medical advice.

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