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JOURNAL ONKOLOGIE – STUDIE
MonumenTAL-3

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

Rekrutierend

NCT-Nummer:
NCT05455320

Studienbeginn:
Oktober 2022

Letztes Update:
24.04.2024

Wirkstoff:
Talquetamab, Daratumumab, Pomalidomide, Dexamethasone

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations
(3 von 216)

Charite Campus Benjamin Franklin
12203 Berlin
(Berlin)
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Asklepios Klinik Altona
22763 Hamburg
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Universitaetsklinikum Heidelberg
69120 Heidelberg
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Universitaetsklinikum Koelnt
50937 Koeln
(Nordrhein-Westfalen)
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Universitaetsklinikum Leipzig
04103 Leipzig
(Sachsen)
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Universitätsmedizin der Johannes Gutenberg Universität
55131 Mainz
(Rheinland-Pfalz)
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Universitaetsklinikum Wuerzburg
97080 Wuerzburg
(Bayern)
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The University of Arizona Cancer Center
85719 Tucson
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University of Arkansas for Medical Sciences
72205 Little Rock
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Norwalk Hospital-oncology
06850 Norwalk
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MedStar Georgetown University Hospital
20007 Washington
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George Washington University
20037 Washington
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Memorial Healthcare System
33021 Hollywood
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33136 Miami
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University Of Illinois
60612 Chicago
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70112 New Orleans
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Ochsner Health System
70121-2429 New Orleans
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21205 Baltimore
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Boston University Medical Center
02118 Boston
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01655 Worcester
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48109 Ann Arbor
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55455 Minneapolis
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39216 Jackson
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Washington University School of Medicine
63110-1032 Saint Louis
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08901 New Brunswick
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13210 Syracuse
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27599 Chapel Hill
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28204 Charlotte
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27157 Winston-Salem
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44106 Cleveland
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43210 Columbus
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19107-4215 Philadelphia
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29425-8900 Charleston
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77030 Houston
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77030 Houston
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79410 Lubbock
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84112 Salt Lake City
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22903 Charlottesville
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23298 Richmond
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98109 Seattle
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1340 Ottignies
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100006 Beijing
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100034 Beijing
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200065 Shanghai
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200434 Shanghai
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518036 Shenzhen
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215006 Su Zhou
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300320 Tianjin
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430030 Wuhan
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500 05 Hradec Kralove
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115 28 Athens Attica
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9103102 Jerusalem
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6423906 Tel Aviv
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60126 Ancona
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40138 Bologna
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20162 Milano
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35128 Padova
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00193 Roma
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71013 San Giovanni Rotondo
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A.O.U. Città della Salute e della Scienza
10126 Torino
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Tokyo Medical and Dental University Hospital
113-8519 Bunkyo-Ku
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814-0180 Fukuoka
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573-1191 Hirakata
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Japanese Red Cross Society Himeji Hospital
670-8540 Hyogo
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277 8577 Kashiwa
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343-8555 Koshigaya
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860-8556 Kumamoto
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Kyoto Kuramaguchi Medical Center
603-8151 Kyoto
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399-8701 Matsumoto
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951-8566 Niigata
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739-0696 Otake
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602 812 Busan
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10408 Gyeonggi-do
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54907 Jeonju-si
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05505 Seoul
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80-214 Gdansk
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25-734 Kielce
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30 688 Krakow
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20090 Lublin
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10-228 Olsztyn
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08025 Barcelona
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11407 Jerez de la Frontera
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37007 Salamanca
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38320 San Cristóbal de La Laguna
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80756 Kaohsiung
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704 Tainan
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06200 Ankara
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06590 Ankara
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35330 Izmir
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Studien-Informationen

Detailed Description:

Overall rationale of the study is that combination treatments of talquetamab, daratumumab,

pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of

relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is

divided into 3 phases: screening, treatment (until confirmed progressive disease, death,

intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first),

and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of

the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic

examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical

laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and

biomarkers will be assessed at specified time points. Total duration of study will be up to 6

years 6 months.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the

International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable

disease at screening as defined by any of the following: i) Serum M-protein level

greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii)

Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii)

Light chain multiple myeloma without measurable M-protein in the serum or the urine:

serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central

laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio

- Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an

initial response to prior treatment, followed by confirmed progressive disease by IMWG

criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease

is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein

(M-protein) or confirmed progressive disease by IMWG criteria during previous

treatment or less than or equal to (<=) 60 days after cessation of treatment

- Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor

(PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma

therapy must be considered lenalidomide-refractory (that is, have demonstrated

progressive disease by IMWG criteria on or within 60 days of completion of

lenalidomide-containing regimen). Participants who have received >=2 prior lines of

antimyeloma therapy must be considered lenalidomide exposed

- Documented evidence of progressive disease based on investigator's determination of

response by the IMWG criteria on or after their last regimen

- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or

2 at screening and immediately prior to the start of administration of study treatment

Exclusion Criteria:

- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to

study drug excipients

- Disease is considered refractory to an anti-cluster of differentiation 38 (CD38)

monoclonal antibody as defined per IMWG consensus guidelines (progression during

treatment or within 60 days of completing therapy with an anti-CD38 monoclonal

antibody)

- Received prior pomalidomide therapy

- A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or

equivalent within 14-day period before the first dose of study drug

- Known active central nervous system (CNS) involvement or exhibits clinical signs of

meningeal involvement of multiple myeloma. If either is suspected, negative whole

brain magnetic resonance imaging (MRI) and lumbar cytology are required

- Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's

macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin

changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to 6 years 6 months):
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.



Secondary outcome:

1. Overall Response (Partial Response [PR] or Better) (Time Frame - Up to 6 years 6 months):
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.

2. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 6 years 6 months):
VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.

3. Complete Response (CR) or Better Rate (Time Frame - Up to 6 years 6 months):
CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.

4. Overall Minimal Residual Disease (MRD) Negative CR (Time Frame - Up to 6 years 6 months):
MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.

5. Overall Survival (OS) (Time Frame - Up to 6 years 6 months):
OS is defined as the time from the date of randomization to the date of the participant's death.

6. Progression-free Survival on Next-line Therapy (PFS2) (Time Frame - Up to 6 years 6 months):
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.

7. Time to Next Therapy (TTNT) (Time Frame - Up to 6 years 6 months):
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.

8. Number of Participants with Adverse Events (AEs) (Time Frame - Up to 6 years 6 months):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

9. Number of Participants with AEs by Severity (Time Frame - Up to 6 years 6 months):
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

10. Serum Concentrations of Talquetamab (Time Frame - Up to 6 years 6 months):
Serum concentrations of talquetamab will be reported.

11. Serum Concentrations of Daratumumab (Time Frame - Up to 6 years 6 months):
Serum concentrations of daratumumab will be reported.

12. Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab (Time Frame - Up to 6 years 6 months):
Number of participants with presence ADAs to talquetamab will be reported.

13. Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab (Time Frame - Up to 6 years 6 months):
Number of participants with presence of ADAs to daratumumab will be reported.

14. Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) (Time Frame - Up to 6 years 6 months):
The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).

15. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c (Time Frame - Up to 6 years 6 months):
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.

16. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 6 months):
Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.

17. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE (Time Frame - Up to 6 years 6 months):
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.

18. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) (Time Frame - Up to 6 years 6 months):
The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.

19. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) (Time Frame - Up to 6 years 6 months):
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.

20. Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) (Time Frame - Baseline up to 6 years 6 months):
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.

21. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c (Time Frame - Baseline up to 6 years 6 months):
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.

22. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 (Time Frame - Baseline up to 6 years 6 months):
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.

23. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE (Time Frame - Baseline up to 6 years 6 months):
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.

24. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) (Time Frame - Baseline up to 6 years 6 months):
The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.

25. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) (Time Frame - Baseline up to 6 years 6 months):
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.

Studien-Arme

  • Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
    Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
    Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
    Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Geprüfte Regime

  • Talquetamab (JNJ-64407564):
    Talquetamab will be administered subcutaneously.
  • Daratumumab:
    Daratumumab will be administered subcutaneously.
  • Pomalidomide:
    Pomalidomide will be administered orally.
  • Dexamethasone:
    Dexamethasone will be administered orally or intravenously.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment"

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