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BLENREP is indicated in adults for the treatment of multiple myeloma:2

  • In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
  • In combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide
Explore the DREAMM-7 study design

DREAMM-7 patient demographics and study design

DREAMM-7: BVd vs DVd eligibility criteria and patient characteristics

DREAMM-7 efficacy data showed that the BLENREP triplet (BVd) demonstrated superiority compared to a daratumumab triplet (DVd), achieving an estimated progression-free survival (PFS) of 36.6 months (95% confidence interval [CI]: 28.4–NR) vs 13.4 months (95% CI: 11.1–17.5), respectively (hazard ratio [HR]: 0.41; 95% CI: 0.31–0.53; P<0.00001).1,2 Evidence showed a 59% reduction in the risk of disease progression or death with BVd vs DVd.1,2

The most frequent side effects (≥20%) in BVd included reduced visual acuity (89%), thrombocytopenia (87%), corneal examination findings (86%), blurred vision (66%), dry eye (51%), photophobia (47%), foreign body sensation in eyes (44%), eye irritation (43%), eye pain (32%), diarrhoea (32%), and upper respiratory tract infection (20%).2

Serious side effects of BVd occurred in 50% of patients. Serious side effects in ≥2% of patients included pneumonia (11%), pyrexia (5%), thrombocytopenia (5%), and anaemia (2%). Fatal side effects occurred in 10% of patients and the most common was pneumonia (3%).2

BLENREP dosing can be delayed, reduced or discontinued as part of a strategy to manage side effects.*2

*Discontinuation rate of any component therapy in the DREAMM-7 study was 31%.

Discover more about the efficacy and safety profile in DREAMM-7

Discover more information on BLENREP dosing, administration and special warnings

DREAMM-7 patient demographics and study design

In DREAMM-7, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients), and treatment was continued until the occurrence of progressive disease, unacceptable toxic effects, withdrawal of consent, or death. There was a median follow-up of 28.2 months and 39.4 months for progression-free survival (PFS) and overall survival (OS) respectively.2,3 The primary endpoint was PFS, and secondary endpoints included OS, overall response rate (ORR), duration of response (DoR), and minimal residual disease (MRD)-negative status.4

DREAMM-7 study design1

Image showing the BLENREP + Vd study design

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†For patients who discontinue due to reasons other than PD.1,2 ‡For patients who discontinue due to PD or other reasons.4

DREAMM-7: BVd vs DVd eligibility criteria and patient characteristics

Among those in the BVd treatment group in DREAMM-7, clinically relevant characteristics included:1

Image of a capsule

52% of patients had prior lenalidomide exposure, and 33% were refractory to lenalidomide.

Image of a capsule

28% of patients had high-risk cytogenetics.

Among those in the DVd treatment group, clinically relevant characteristics included 52% of patients who had prior lenalidomide exposure and 35% were refractory to lenalidomide. 27% of patients had high-risk cytogenetics.

  • Eligibility criteria1,4

    Participants in DREAMM-7 were subject to the following eligibility criteria:1,4

    Key inclusion criteria: Key exclusion criteria:
    • Adults with MM
    • ≥1 prior line of MM therapy
    • Progressive disease during or after most recent therapy
    • Prior treatment with anti-BCMA
    • Prior allogeneic stem cell transplant
    • Refractory to or intolerant of daratumumab or bortezomib
    • Current corneal epithelial disease*
    • Ongoing Grade ≥2 peripheral neuropathy or neuropathic pain

    Stratification:

    • R-ISS stage (I vs II/III)
    • Prior lines of treatment (1 vs 2 or 3 vs ≥4)
    • Prior bortezomib (yes or no)

    No more than 50% of patients with 2 or more lines of treatment were enrolled. No crossover was allowed.

    *Only patients with current corneal epithelial disease were excluded. Patients with prior or pre-existing eye-related issues, including current mild punctate keratopathy, were not excluded.

  • The trial population in DREAMM-7 was closely representative of the population of patients with MM in terms of the sex and age distribution. However, the trial population had more White patients than patients in other racial groups, with an underrepresentation of Black patients.1

    Table of patient characteristics in DREAMM-71

    BVd (N=243) Characteristics DVd (N=251)
    65.0 (34.0-86.0) Median age (yr), (range) 64.0 (32.0-89.0)
      Age category, n (%)  
    121 (50%) 18 to <65 yr 126 (50%)
    122 (50%) ≥65 yr 125 (50%)
      Race*, n (%)  
    206 (85%) White 203 (81%)
    8 (3%) Black 12 (5%)
    28 (12%) Asian 33 (13%)
      R-ISS disease stage at screening, n (%)  
    102 (42%) Stage I 103 (41%)
    130 (53%) Stage II 132 (53%)
    9 (4%) Stage III 14 (6%)
    2 (1%) Unknown 2 (1%)
      Extramedullary disease, n (%)  
    13 (5%) Yes 25 (10%)
    230 (95%) No 226 (90%)
    232/242 (96%) ECOG performance status ≤1†, n/N (%) 235/246 (96%)
    67 (28%) Patients with high-risk cytogenetics‡, n (%) 69 (27%)
    164 (67%) Prior stem cell transplant, n (%) 173 (69%)

    *Race was reported by the investigators. †The ECOG performance status scores range from 0–5 with higher scores indicating greater disability. ‡High-risk cytogenetic factors included [positive for t(4;14), t(14;16), or 17p13del].1

  • The trial population in DREAMM-7 was closely representative of the population of patients with MM in terms of the sex and age distribution. However, the trial population had more White patients than patients in other racial groups, with an underrepresentation of Black patients.1

    Prior treatment exposure1

    BVd (N=243) Previous lines of therapy, % (n) DVd (N=251)
    51% (125) 1 50% (125)
    36% (88) 2 or 3 39% (99)
    12% (30) ≥4 11% (27)
    90% (218) Prior proteasome inhibitor, % (n) 86% (216)
    86% (210)  Prior bortezomib, % (n) 84% (211)
    52% (127) Prior lenalidomide, % (n) 52% (130)
    33% (79) Refractory to lenalidomide, % (n) 35% (87)
    1% (3) Prior daratumumab, % (n) 2% (4)

Explore the efficacy and safety profile of BVd in DREAMM-7

Abbreviations

AE, adverse event; BCMA, B-cell maturation antigen; BVd, belantamab mafodotin, bortezomib and dexamethasone; CBR, clinical benefit rate; CI, confidence interval; CRR, complete response rate; DoR, duration of response; DVd, daratumumab, bortezomib and dexamethasone; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; HRQoL, health-related quality of life; IRC, independent review committee; ITT, intention-to-treat; IV, intravenous; MM, multiple myeloma; MRD, minimal residual disease; NR, not reached; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; QW, once a week; Q3W, once every 3 weeks; Q4W, once every 4 weeks; Q12W, once every 12 weeks; R-ISS, Revised International Staging System; RRMM, relapsed refractory multiple myeloma; SC, subcutaneous; TTP, time to progression; TTR, time to response; Vd, bortezomib and dexamethasone; yr, year.

References

  1. Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2024 Aug 1;391(5):393–407.
  2. BLENREP. Summary of Product Characteristics. GlaxoSmithKline; 2025.
  3. Hungria V, Robak P, Hus M, et al. Belantamab mafodotin, bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: Overall survival analysis and updated efficacy outcomes of the Phase 3 DREAMM-7 Trial. Presented at: 66th American Society of Hematology (ASH) Annual Meeting & Exposition; December 7-10, 2024; San Diego, CA, and virtual.
  4. Hungria V, Robak P, Hus M, et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(5):393–407, Supplemental Appendix.

▼This product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (available on the Apple App Store or Google Play Store). Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or UKSafety@GSK.com.

October 2025 | PM-GB-BLM-WCNT-250003 (V1.0)