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Clinical Trials in Denmark / NCT03314636
Active, not recruiting Phase 2

Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

NCT03314636 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2018-03-16
Last updated
2025-08-08

Condition(s) studied

Myeloma

Investigational drug(s) / intervention(s)

Carfilzomib →Lenalidomide →PET-CTDexamethasone →

Carfilzomib: See in arm description

Lenalidomide: See in arm description

PET-CT: See in arm description

Dexamethasone: See in arm description

Study summary

A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Prior confirmed diagnosis of multiple myeloma (2014). 2. Received standard first line treatment with at least partial response. Standard first line treatment is defined as * VRD, VTD or VCD followed by ASCT, or * MPV at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or * Rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles. 3. Carfilzomib naïve. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count \>35 x 109/L. 6. At least very good partial remission (VGPR) from first line treatment Exclusion Criteria: 1. Change of first line treatment because of stabile or progressive disease. 2. Major surgery within 28 days before enrollment. 3. Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment. 4. Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone. 5. Central nervous system involvement. 6. Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment 7. Uncontrolled hypertension or uncontrolled diabetes despite medication 8. Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity. 9. Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 10. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark
Odense University Hospital Odense Denmark
Oslo University Hospital Oslo Norway
Skåne University Hospital Lund Sweden

On this site

📄 Revlimid (lenalidomide) drug profile →

More Oslo University Hospital trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03314636 on ClinicalTrials.gov ↗ ← All trials in Denmark