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JOURNAL ONKOLOGIE – STUDIE
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A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT03859427

Studienbeginn:
Mai 2019

Letztes Update:
15.04.2021

Wirkstoff:
Carfilzomib, Lenalidomide, Dexamethasone

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 107)

Research Site
50924 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Research Site
92708 Fountain Valley
United StatesAbgeschlossen» Google-Maps
Research Site
54511 Vandoeuvre les Nancy Cedex
FranceRekrutierend» Google-Maps
Research Site
660022 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
Research Site
185019 Petrozavodsk
Russian FederationRekrutierend» Google-Maps
Research Site
197341 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with

lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered

twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects

with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Documented relapse or progressive multiple myeloma after last treatment. Subjects

refractory to the most recent line of therapy are eligible, unless last treatment contained

PI or lenalidomide and dexamethasone). Refractory is defined as disease that is

nonresponsive or progresses within 60 days of last therapy.

Subjects must have at least PR to at least 1 line of prior therapy.

Subjects must have received at least 1 but not more than 3 prior lines of therapy for

multiple myeloma (induction therapy followed by stem cell transplant and consolidation

maintenance therapy will be considered as 1 line of therapy).

Prior therapy with a PI or the combination of lenalidomide and dexamethasone are allowed,

if, the patient had at least a PR to the most recent therapy with a PI or lenalidomide and

dexamethasone, neither PI or lenalidomide and dexamethasone in combination were ceased due

to toxicity (unless at the time of enrollment that toxicity was neuropathy not exceeding

grade 2 which has either resolved or if ongoing is less than or equal to grade 1), the

patient has not received a PI and has not received lenalidomide and dexamethasone in

combination in the 6 months prior to first study treatment. (Patients are permitted to have

received single agent lenalidomide as maintenance therapy during the 6 months prior to

first treatment)

Previous treatment with a lenalidomide and dexamethasone containing regimen is allowed, as

long as the subject did not progress during the first 3 months after initiating

lenalidomide and dexamethasone containing therapy.

Measurable disease with at least 1 of the following assessed within 21 days prior to

randomization:

- Inmunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level ≥

1.0 g/dL

- Inmunoglobulin A (IgA), Inmunoglobulin D (IgD), Inmunoglobulin E (IgE) multiple

myeloma: serum M-protein level ≥ 0.5 g/dL

- Urine M-protein ≥ 200 mg per 24 hours

- In subjects without measurable serum or urine M-protein, serum-free light chain (SFLC)

≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio

Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 ≤ 2

Other inclusion criteria may apply

Exclusion Criteria:

Waldenström macroglobulinemia.

Multiple myeloma of Inmunoglobulin M (IgM) subtype.

Plasma cell leukemia (> 2.0 × 10^9 /L circulating plasma cells by standard differential).

Uncontrolled hypertension, defined as a subject whose blood pressure exceeds ≥ 160 mmHg

systolic or ≥ 100 mmHg diastolic when taken in accordance with the European Society of

Hypertension/European Society of Cardiology 2018 guidelines.

Active congestive heart failure (New York Heart Association Class III to IV), symptomatic

ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of > 470

msec, pericardial disease, or myocardial infarction within 4 months prior to randomization.

Calculated or measured creatinine clearance < 1.0 mL/s (calculation must be based on the

Cockcroft and Gault formula) within 21 days prior to randomization.

Other exclusion criteria may apply

Studien-Rationale

Primary outcome:

1. Overall Response Rate (ORR) (Time Frame - Through study completion, an average of 14 months):
ORR defined as the proportion of best overall response of stringent complete response [sCR], complete response [CR], very good partial response [VGPR] and partial response [PR] per International Myeloma Working Group Uniform Response Criteria [IMWG-URC]



Secondary outcome:

1. Progression free survival (PFS) (Time Frame - Through study completion, an average of 14 months)

2. Convenience (Time Frame - Through study completion, an average of 14 months):
As measured by the Patient-reported convenience with carfilzomib dosing schedule question

3. Subject incidence of treatment-emergent adverse events (Time Frame - Through study completion, an average of 14 months)

4. Additional efficacy parameter - Time to Response (Time Frame - Through study completion, an average of 14 months):
As measured by Time to Response (TTR)

5. Additional efficacy parameter - Duration of Response (Time Frame - Through study completion, an average of 14 months):
Duration of Response (DOR)

6. Additional efficacy parameter - Time to Progression (Time Frame - Through study completion, an average of 14 months):
Time to Progression (TTP)

7. Overall Survival (Time Frame - Through study completion, an average of 14 months)

8. MRD[-]CR rate (Time Frame - Through study completion, an average of 14 months):
Defined as achievement of CR or better by Independent Review Committee (IRC) per IMWG-URC and achievement of Minimal Residual Disease (MRD) negativity as assessed by next-generation sequencing method at a 10^ -5 threshold

9. MRD[-] rate at 12 months (Time Frame - 12 months):
Defined as achievement of Minimal Residual Disease (MRD) negativity at 12 months (+/- 2 weeks) from randomisation as assessed by next-generation sequencing method at a 10^ -5 threshold

10. Physical functioning and role functioning (Time Frame - Through study completion, an average of 14 months):
As measured by the Physical Functioning and Role Functioning scales of the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30), a 30-item generic instrument for use in cancer subjects across tumor types

11. Treatment satisfaction as measured by the Satisfaction with Therapy (SWT) subscale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) (Time Frame - 4 months):
Cancer Therapy Satisfaction Questionnaire (CTSQ) - measures treatment satisfaction in individuals with cancer

Studien-Arme

  • Active Comparator: Carfilzomib once-weekly
    Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using once-weekly carfilzomib 56 mg/m2
  • Active Comparator: Carfilzomib twice-weekly
    Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using twice-weekly carfilzomib 27 mg/m2

Geprüfte Regime

  • Carfilzomib:
    Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
  • Carfilzomib:
    Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.
  • Lenalidomide:
    Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent
  • Dexamethasone:
    Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent

Quelle: ClinicalTrials.gov


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