Clinical trial NCT03314636: Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.
Official title: KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Myeloma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Nordic Myeloma Study Group
First posted: 2017-10-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (VGPR). Eligible performed regimens are defined in the protocol. All patients will perform a PET-CT, and PET-negative patients will be excluded from protocol treatment. The PET-positive patients will do a minimal residual disease (MRD-)evaluation in the bone marrow before entering treatment. After 4 28day cycles of Carfilzomib-Revlimid-Dexamethason, a new MRD and a new PET-CT will be performed, as measures of outcome. Patients will continue treatment as written in the protocol.

Eligibility criteria: 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 outcomes:
measure: PET negativity after induction
timeFrame: 1 month after induction
Secondary outcomes:
measure: PET correlation with MRD Euroflow
timeFrame: 1 month after induction
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
References: