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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma:...in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
Secondary therapy:
dexamethasone
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
...the NCCN panel has included daratumumab/pomalidomide/dexamethasone as a treatment option for patients with relapsed/refractory MM... Multiple Myeloma: Therapy for previously treated multiple myeloma…Other Recommended Regimens… Daratumumab /pomalidomide /dexamethasone
Secondary therapy:
dexamethasone
Evidence Level:
Sensitive: B - Late Trials
Title:

Subcutaneous daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (APOLLO): extended follow up of an open-label, randomised, multicentre, phase 3 trial

Published date:
10/05/2023
Excerpt:
At a median follow-up of 39·6 months (IQR 37·1-43·7), median overall survival was 34·4 months (95% CI 23·7-40·3) in the daratumumab plus pomalidomide and dexamethasone group...the safety profile results with long-term follow-up reported here continue to support the use of daratumumab plus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.
Secondary therapy:
dexamethasone
DOI:
10.1016/S2352-3026(23)00218-1
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Overall Survival Results from the Phase 3 Apollo Study

Published date:
11/03/2022
Excerpt:
After >3 years of follow-up in APOLLO, a clinically meaningful improvement in median OS of 10.7 months was observed with D-Pd versus Pd. The addition of DARA to Pd improved PFS2 compared to Pd alone. No new safety concerns were identified with longer follow-up. Our results, together with the OS benefit observed with DARA-containing regimens in the ALCYONE, MAIA, CASTOR, and POLLUX studies, continue to support the use of DARA in patients with multiple myeloma.
Secondary therapy:
dexamethasone
DOI:
https://doi.org/10.1182/blood-2022-163483
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Apollo: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)Clinically Relevant Abstract

Published date:
11/04/2020
Excerpt:
In this phase 3 study evaluating DARA SC plus Pd, D-Pd significantly reduced the risk of progression or death by 37% in pts with RRMM who had received ≥1 prior line of therapy vs Pd alone.
Secondary therapy:
dexamethasone
Evidence Level:
Sensitive: B - Late Trials
Title:

Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Published date:
07/31/2020
Excerpt:
Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma...Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone….The study met the primary endpoint of improving progression-free survival (PFS).
Secondary therapy:
dexamethasone