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DARZALEX® (daratumumab)

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DARZALEX + DARZALEX FASPRO - Use in Patients with Multiple Myeloma and Requires Dialysis

Last Updated: 05/22/2025

Click on the following links to related sections within the document: Phase 2 DARE Study and Retrospective Studies.
Abbreviations: CrCl, creatinine clearance; ESRD, end-stage renal disease; IgG, immunoglobulin G; IV, intravenous; mAb, monoclonal antibody; PK, pharmacokinetic; SC, subcutaneous.
aData on File (2024a).1 bData on File (2024b).2 cMascelli (2007).3 dTabrizi (2006).4

Click on the following links to related sections within the document: Phase 2 DARE Study and Retrospective Studies.
Abbreviations: AE, adverse event; CI, confidence interval; CR, complete response; eGFR, estimated glomerular filtration rate; FLC, free light chain; IRR, infusion-related reaction; IV, intravenous; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetic; PR, partial response; RRMM, relapsed or refractory multiple myeloma; RRR, renal response rate; SAE, serious adverse event; SC, subcutaneous; VGPR, very good partial response.
aLonial (2016).5 bLokhorst (2015).6 cDimopoulos (2016).7 dPalumbo (2016).8 eChari (2017).9 fFacon (2019).10 gUsmani (2019).11 hChari (2019).12 iKastritis (2020).13 jKastritis (2023).14 kKastritis (2023).15 lCejalvo (2021).16 mGrade 1; observed only during the first infusion. nFenoglio (2023)17. oNiewinski (2022).18 pKuzume (2020).19 qRocchi (2018).20 rSmyth (2019).21 sJeyaraman (2020).22 tMizuno (2020).23 uTurgutkaya (2021).24 vMizuno (2021).25 wTsushima (2021).26 xHaidar (2021).27 yKolagatla (2022).28

PRODUCT LABELING

CLINICAL DATA

Phase 2 Study with DARZALEX

Kastritis et al (2020)13 reported preliminary efficacy and safety results of DARZALEX in patients with relapsed or refractory multiple myeloma (RRMM) and severe renal impairment or in need of hemodialysis using data from the phase 2 DARE study.

Study Design/Methods

  • Prospective, phase 2, multicenter, single-arm, open-label study
  • Inclusion criteria: Patients with RRMM and severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 or in need of hemodialysis) who had ≥2 prior lines of therapy with both bortezomib- and lenalidomidebased regimens, with an Eastern Cooperative Oncology Group performance status (ECOG PS) score of ≤2, and no prior exposure to anticluster of differentiation 38 (CD38) antibody treatment (including DARZALEX) were included.
  • Patients received DARZALEX 16 mg/kg intravenous (IV) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks for subsequent cycles. In addition, patients received dexamethasone oral (PO) 40 mg weekly, every cycle.  
  • Primary endpoint: progression-free survival (PFS)
  • Secondary endpoints: overall response rate (ORR), renal response rate (RRR; proportion of patients with ≥ best response of renal partial response [PR]) as per the International Myeloma Working Group (IMWG) criteria

Results

Patient Characteristics

Baseline Patient Characteristics in DARE Study13
N=35
Median age, years
72
Median time from diagnosis to 1st DARZALEX dose, years
4.2
Male, %
77.1
Median number of prior therapies
3
Prior ASCT, %
37.1
Median eGFR, mL/min/1.73m2
13
Patients on dialysis, n (%)
17 (48.6)
Median number of cycles
5
Median follow-up duration, months
5.5
Abbreviations: ASCT, autologous stem cell transplant; eGFR, estimated glomerular filtration rate.
Efficacy
  • The 6-month PFS rate was 50%.
  • Overall ORR was 45.7%, very good partial response (VGPR) was reached in 31.4% and PR was reached in 14.3% of patients.
    • ORR was 35.3%, VGPR and PR was 17.6% in patients on dialysis (n=17).
  • Median time from the first dose of study treatment until first response (≥PR) was 0.9 months. RRR was 17.1%.
Safety
  • Of the patients that discontinued treatment, 31.4% was due to disease progression and 17.1% was due to death.
  • Seventeen patients (48.6%) reported at least 1 adverse event (AE). The most frequent AEs reported were anemia (17.6%) and hyperglycemia (8.6%).
  • Nine patients (25.7%) reported at least 1 serious adverse event (SAE). Fatal SAEs reported were septic shock (n=2), lower respiratory tract infection (n=1), myocardial infarction (n=1), performance status decreased (n=1) and peritonitis (n=1, in a patient receiving peritoneal dialysis). Other SAEs were acute kidney injury, cerebrovascular accident, acute kidney injury, hyperkalemia and pneumonia (n=1 each).

Final Analysis of Efficacy and Safety Results of DARE Study

Kastritis et al (2023)14 reported final analysis of efficacy and safety results from the DARE study after a median follow-up of 11.3 months (interquartile range, 3.3-22.5).

Results

Patient Characteristics

Baseline Patient Characteristics in the DARE Study (Final Analysis)14,15
Characteristic
N=38
Median age (range), years
72 (40-89)
Male, n (%)
29 (76.3)
R-ISS stage, n (%)
   Not assessed
2 (5.3)
   II
20 (52.6)
   III
16 (42.1)
ECOG PS, n (%)
   0
15 (39.5)
   1
22 (57.9)
   2
1 (2.6)
Median eGFR (IQR), mL/min/1.73 m2
12 (7-22)
Median number of prior systemic lines of therapies (range)
3 (2-6)
Prior ASCT, n (%)
13 (34.2)
Patients on dialysis, n (%)
17 (44.7)
Abbreviations: ASCT, autologous stem cell transplant; ECOG PS, Eastern Cooperative Oncology Group performance status; eGFR, estimated glomerular filtration rate; IQR, interquartile range; R-ISS, revised International Staging System.
Efficacy
  • The median PFS was 11.8 months (95% CI, 2.8-20.8). The 6-month and 12-month PFS rates were 54.0% and 48.1% respectively.14
  • The median PFS for dialysis patients was 2.8 (95% CI, 1.2-16.1) months and 13.3 (95% CI, 3.9-NR) months for non-dialysis patients (P=0.358).14
  • Efficacy outcomes are summarized in Table: Efficacy Outcomes of the DARE Study.

Efficacy Outcomes of the DARE Study14,15
Parameter
Patients on Hemodialysis
(n=17)
Patients not on Hemodialysis
(n=21)
All Patients (N=38)
ORR, n (%)
8 (47.1)
10 (47.6)
18 (47.4)
VGPR, n (%)
5 (29.4)
8 (38.1)
13 (34.2)
PR, n (%)
3 (17.6)
2 (9.5)
5 (13.2)
MR, n (%)
0 (0)
3 (14.3)
3 (7.9)
Renal response
Partial/complete response, n (%)
1 (5.9)
6 (28.6)
7 (18.4)
No response/minor response, n (%)
16 (94.1)
15 (71.4)
31 (81.6)
RRR, n (%)
1 (5.9)
6 (28.6)
7 (18.4)
Median time to first response ≥PR (IQR), months
0.9 (0.9-1.0)
0.9 (0.9-2.7)
0.9 (0.9-1.0)
Median duration of response ≥PR (95% CI), months
NR
(1.8-NR)
28.4
(3.5-NR)
28.4
(15.1-NR)
Median OS (95% CI), months
12.5 (2.2-NR)
24.5 (10.1-NR)
24.5 (5.5-NR)
Abbreviations: CI, confidence interval; IQR, interquartile range; MR, minimal response; NR, not reached; ORR, overall response rate; OS, overall survival; PR, partial response; RRR, renal response rate; VGPR, very good partial response.
Safety
  • The most frequently reported grade 3/4 AEs were anemia (n=6; 15.8%), hyperglycemia (n=5; 13.2%), and hypercalcemia (n=3; 7.9%).15
  • Twelve SAEs were reported in 11 patients (28.9%).14
    • The most frequently reported SAE was septic shock (n=4; 10.5%).
    • One patient experienced grade 3 pneumonia requiring hospitalization
    • Two deaths due to infections were reported, 1 patient on peritoneal dialysis due to peritonitis and another patient due to lower respiratory tract infection.
    • SAE of acute kidney injury was reported in 1 patient.
    • Three patients required dialysis during treatment due to disease progression.

Retrospective, Multicenter, Open-label Study

Cejalvo et al (2020)16 reported results of a retrospective, multicenter, open-label study to evaluate the safety and efficacy of DARZALEX in Spanish patients (N=15) with RRMM with end-stage renal failure requiring dialysis.

Study Design/Methods

  • Inclusion criteria: ≥18 years, documented disease progression by IMWG criteria following most recent therapy including a proteasome inhibitor (PI) and an immunomodulatory drug or double-refractory to a PI and an immunomodulatory drug, ECOG PS 0-2, absence of chronic obstructive pulmonary disease (COPD) or persistent asthma, no prior anti-CD38 therapy, end-stage renal failure requiring dialysis.
  • Patients received DARZALEX 16 mg/kg IV weekly for 8 weeks, then every 2 weeks for 16 weeks, and every 4 weeks thereafter until disease progression or unacceptable toxicity.
  • All patients received DARZALEX treatment after dialysis was completed.
  • Pre-infusion medications included methylprednisolone 100 mg IV for cycles 1-2 and 60 mg for subsequent infusions, acetaminophen 650-1000 mg, and diphenhydramine 25-50 mg; post-infusion medications consisted of 2 consecutive days of methylprednisolone 20 mg; montelukast 10 mg was also included but was not mandatory.
  • Primary endpoint: ORR
  • Data were collected on anti-multiple myeloma (MM) activity and AEs including grade 3/4 AEs and infusion-related reactions (IRRs).

Results

  • Median number of cycles of DARZALEX administered was 7 (range, 1-19).
  • No patient became dialysis independent.
  • The baseline patient characteristics are summarized in Table: Baseline Patient Characteristics.

Baseline Patient Characteristics16
Characteristic
DARZALEX (N=15)
Median (range) age, years
62 (51-71)
Gender, male/female, n
10/5
MM type, n
   Bence Jones/IgA/IgD/IgG
8/2/1/4
Median (range) number of prior therapies, n
3 (2-6)
   >3 lines (n)
33% (5)
Median (range) cycles of DARZALEX administered, n
7 (1-19)
Dialysis requirements, n
   Non-MM related/MM-related
1/14
   Acute renal injury at time of MM diagnosis
5
Median (range) time from diagnosis to initiation of DARZALEX, years
2 (0.47-13.77)
Median (range) time on dialysis at start of therapy, months
2.4 (0.26-90.51)
Abbreviations: Ig, immunoglobulin; MM, multiple myeloma.
Efficacy

Efficacy Outcomes16
Parameter
All Patients (N=15)
Median DOR, months (range)
6.14 (1-18.86)
ORR, %
40
   CR, n
1
   VGPR, n
4
   PR, n
1
   SD, n
7
   Refractory to DARZALEX, n
2
Median PFS, months (range)
8.74 (0.56-18.86)
Median OS, months (range)
12.19 (0.5624.80)
Abbreviations: CR, complete response; DOR, duration of response; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SD, stable disease; VGPR, very good partial response.
  • At time of analysis, 11 patients had died.
    • Seven deaths were due to MM-progression and 4 deaths were non-MM related.
    • Of the 4 patients alive at time of analysis, 2 were without progression (1 continuing with DARZALEX treatment and 1 received autologous transplantation).
Safety
  • Most common non-hematologic AEs:
    • IRRs (n=6, grade 1; observed only during the first infusion)
    • Asthenia and hypotension were also reported.
  • Most common grade 3/4 hematologic AEs:
    • Anemia (n=4)
    • Thrombocytopenia (n=5)
    • Neutropenia (n=4)
  • AEs leading to death within 30 days after last DARZALEX dose was reported in 4 patients: bacterial infections (n=2), gastrointestinal hemorrhage (n=1) and ventricular fibrillation (n=1).

Retrospective, Single-Center, Chart Reviews

Niewinski et al (2022)18 reported results of a retrospective chart review evaluating the efficacy and safety of DARZALEX in patients (N=101) with relapsed MM and renal impairment who received ≥1 dose of DARZALEX.

Study Design/Methods

  • Outcomes included change in creatinine clearance (CrCl) during treatment, AEs, and survival.

Results

Patient Characteristics
  • All patients received DARZALEX, and 52% of them went on to receive DARZALEX FASPRO.
  • The baseline patient characteristics are summarized in Table: Baseline Patient Characteristics.
  • Median CrCl at MM diagnosis and DARZALEX initiation was 45 mL/min (range, 7.3-101) and 40 mL/min (range, 5.3107), respectively, with 33% of patients having CrCl <30 mL/min.

Baseline Patient Characteristics18
Characteristic
N=101
Median age (range), years
74 (54-92)
Female, n (%)
46 (45.5)
R-ISS stage, %
   I
20
   II
35
   III
45
Patients with high-risk cytogenetics, %
20
Median number of prior lines of therapy, n
2
Patients on hemodialysis, %
14
Median (range) number of infusions,a n
23 (1-60)
   DARZALEX, n
16
   DARZALEX FASPRO, n
10
DARZALEX regimens, %
   DKd
13
   DPd
35
   DRd
32
   DVd
35
Abbreviations: DKd, DARZALEX + carfilzomib + dexamethasone; DPd, DARZALEX + pomalidomide + dexamethasone; DRd, DARZALEX + lenalidomide + dexamethasone; DVd, DARZALEX + bortezomib + dexamethasone; R-ISS, revised International Staging System.
aDARZALEX infusions were delivered over a median of 18 months.
Efficacy
  • Median CrCl in patients after 3 (n=95), 6 (n=89), and 12 (n=69) months of DARZALEXbased regimens was 45, 43, and 41 mL/min, respectively.
  • No differences in renal function were observed in patients who received DARZALEX FASPRO.
  • The 5-year PFS rate was 54%.
  • A total of 16 patients had died at the time of data collection, and the median survival was 63 months.
  • Of the 101 patients, 23% switched to subsequent treatments.
Safety
  • The most common AEs were anemia (37%) and neutropenia (15%).
  • IRRs were reported in 19% of patients.

Retrospective, Single-Center Study

Fenoglio et al (2023)17 reported results of DARZALEX monotherapy in patients with AL amyloidosis and renal involvement (N=17).

Study Design/Methods

  • Patients included had to have a histological confirmation and staging of renal involvement and ineligible for autologous stem cell transplant (ASCT).
  • Patients could be either treatment naïve or refractory.
  • When feasible, a second kidney biopsy was performed at the end of treatment.

Results

Patient Characteristics

  • Mean age was 73 years.
  • Two patients were on dialysis at initiation of therapy.

Efficacy

  • Thirteen of 17 patients  received at least 12 infusions.
  • At 12th infusion, 84.6% had an overall hematologic response.
    • Complete response: 46.5%
    • Very good partial response: 38%
    • No response: 15.5%
  • The 2 patients on dialysis at the time of therapy initiation, remained on dialysis.
  • Proteinuria decreased from 6.02 to 1.28 g/day (P<0.005) with stabilization/improvement in serum creatinine (sCr).
  • Eight out of 9 patients with cardiac involvement obtained at least amelioration.
  • At the end of follow-up 5 patients have persistent hematological and renal response.
  • Seven patients underwent a second kidney biopsy at the end of treatment. Stable deposits occurred in 6 patients and a reduction in the extension and amount of amyloid deposits in 1 patient.
  • The last patient is still alive and being treated with a second line of therapy due to no hematologic or organ response with DARZALEX.

Safety

  • Safety data was not reported.

Kuzume et al (2021)19 reported results of a retrospective, single-center study evaluating the safety and efficacy of patients (N=13) with severe renal failure (≤15 ml/min/1.73 m2) who received at least 8 doses of DARZALEX.

Study Design/Methods

  • Efficacy of DARZALEX was assessed by free light chain (FLC) reduction, measured before, 3, and 7 days after DARZALEX infusion.
  • Treatment response and renal response was assessed utilizing the IMWG criteria.
  • Patients received at least 8 doses of DARZALEX 16 mg/kg and was used for induction or intensification for patients who did not have a CR.

Results

  • A total of 13 patients with severe renal failure were included in this review and 6 patients were on dialysis at diagnosis. Key patient characteristics from the 6 patients on dialysis are summarized in the Table: Key Patient Characteristics of Patients on Dialysis.

Key Patient Characteristics of Patients on Dialysis29
Patient No.
Age, years
Gender
R-ISS
% U-Alb
Renal Pathology
Dialysis at Diagnosis
1
83
F
3
5.5
Amyloidosis, CN
Yes
2
80
M
2
59
LCDD, CN
Yes
3
81
F
3
82.9
IG
Yes
4
64
F
3
72.8
LCDD, CN
Yes
5
80
M
2
19.8
CN
Yes
6
60
M
3
4
NA
Yes
Abbreviations: % U-Alb, percentage of urine albumin; CN, cast nephropathy; F, female; IG, immunotactoid glomerulopathy; LCDD, light chain deposition disease; M, male; NA, not assessed; RISS; revised International Staging System.
Efficacy
  • Median time from diagnosis to DARZALEX infusion was 2 months (range, 0.2-8.1).
  • At the last follow-up, median duration from diagnosis was 23.7 months (range, 3.544.5)
  • Patient responses to DARZALEX and treatments for the 6 patients on dialysis are summarized within the Table: Treatment and Response to DARZALEX for Patients on Dialysis.

Treatment and Response to DARZALEX for Patients on Dialysis29
Patient No.
Time from diagnosis to DARZALEX (months)
Best hematological response at DARZALEX initiation
Previous therapies used prior to DARZALEX
Concomitant tx at DARZALEX initiation
Best hematological response
Renal response
1
3
sCR
Bor, Len, K
DBd
sCR
SD
2
2
CR
Bor, Len, K
DBd
sCR
SD
3
4.1
SD
Bor
DRd
VGPR
SD
4
0.2
NA
None
CyBorD
sCR
SD
5
0.5
NA
Bor, Cy
DKd
sCR
SD
6
0.3
NA
ADM, Bor
DBd
PR
SD
Abbreviations: ADM, Adriamycin; Bor, bortezomib; CR, complete response; Cy, cyclophosphamide; CyBorD, cyclophosphamide + bortezomib + dexamethasone; DBd, DARZALEX + bortezomib + dexamethasone; DKd, DARZALEX + carfilzomib + dexamethasone; DRd, DARZALEX + lenalidomide + dexamethasone; K, carfilzomib; Len, lenalidomide; NA, not assessed; PR, partial response; sCR, stringent complete response; SD, stable disease; tx, therapy; VGPR, very good partial response.
  • Of the 6 patients on dialysis, 3 patients achieved dialysis independence.
  • From completion of the first 8 DARZALEX infusions to the final follow-up, there were no significant increase in eGFR.
  • A >50% FLC reduction 3 days after DARZALEX initiation was seen in 10 out of 13 patients.
    • After the first DARZALEX infusion, median FLC reduction was observed in 69.6% patients (range, 14.3%-89.2%).
Safety

AEs in Patients with Severe Renal Failure on DARZALEX29
Adverse event, n (%)
Grades 1/2
Grades 3/4
Infusion reaction
4 (31)
0
Pneumonia
0
1 (8)
CMV infection
1 (8)
2 (15)
Congestive heart failure
0
1 (8)
Ileus
1 (8)
0
Pruritis
2 (15)
0
Decreased platelets
1 (8)
0
Abbreviation: CMV, cytomegalovirus.
  • After the first dose of DARZALEX, 31% of patients reported grade 1/2 infusion reaction.
  • Grade 3 congestive heart failure and pneumonia were reported in 2 patients and DARZALEX infusion was re-initiated after treatment with ganciclovir.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 13 January 2025.

 

References

Show
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