Table 1 Summary of best confirmed responsea and MRD-negativeb rates.

From: Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study

Variable

D-Rd (n = 281)

Rd (n = 276)

P

Overall response

    No. with response

261

211

 

    Rate, % (95% CI)

92.9 (89.2–95.6)

76.4 (71.0–81.3)

< 0.0001c

Clinical benefit, n (%)d

266 (94.7)

237 (85.9)

 

Best overall response, n (%)

    CR or better

159 (56.6)

64 (23.2)

< 0.0001c

        Stringent CRe

82 (29.2)

29 (10.5)

 

        CR

77 (27.4)

35 (12.7)

 

    VGPR or better

226 (80.4)

136 (49.3)

< 0.0001c

    VGPR

67 (23.8)

72 (26.1)

 

    Partial response

35 (12.5)

75 (27.2)

 

    Stable diseasef

18 (6.4)

59 (21.4)

 

    Progressive disease

0 (0.0)

4 (1.4)

 

    Response could not be evaluated

2 (0.7)

2 (0.7)

 

MRD negative (10−5)

n = 286

n = 283

 

    n (%)

87 (30.4)

15 (5.3)

< 0.0001g

  1. Response was assessed according to the Uniform Criteria Consensus recommendations of the International Myeloma Working Group [17, 18]. The analysis included patients who had a confirmed diagnosis of MM and measurable disease at baseline or screening. In addition, patients had received at least one administration of trial treatment and had at least one disease assessment after the baseline visit.
  2. MRD minimal residual disease, D-Rd daratumumab/lenalidomide/dexamethasone, Rd lenalidomide/dexamethasone, CI confidence interval, CR complete response, VGPR very good partial response.
  3. aResponse-evaluable population.
  4. bIntent-to-treat population.
  5. cP value was calculated using the Cochran–Mantel–Haenszel chi-square test.
  6. dClinical benefit includes all patients with minimal response, partial response, VGPR, CR, and stringent CR.
  7. eCriteria for a stringent CR include the criteria for a CR plus a normal free light-chain ratio and the absence of clonal plasma cells as assessed by immunohistochemical or immunofluorescence analysis or by flow cytometry.
  8. fIncludes patients who achieved a minimal response.
  9. gP value was calculated using the Fisher’s exact test.