Kyprolis-Revlimid-dexamethasone consolidation treatment in myeloma patients with a positive PET-CT after standard first line treatment

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-000586-72-PT
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-30
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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, with or without lenalidomide maintenance
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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.
4. Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
5. Patients who started treatment more than 12 month before screening
6. Central nervous system involvement.
7. 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
8. Uncontrolled hypertension or uncontrolled diabetes despite medication
9. Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
10. 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.
11. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
12. Not expected to tolerate full dose KRd

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified