Kyprolis-Revlimid-dexamethasone consolidation treatment in myeloma patients with a positive PET-CT after standard first line treatment. A phase II study

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-NO

Lead Sponsor: Oslo University Hospital

Brief Summary: Not available

Detailed Description: Not available

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 very good partial response (VGPR). 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.

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, 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, IgM multiple myeloma, POEMS syndrome, myelodysplastic syndrome.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the proportion of patients that are PET-positive after standard first line treatment, and how many of these can become PET-negative after 4 cycles of KRd (Kyprolis-Revlimid-dexamethasone) consolidation.<br>;Secondary Objective: The correspondence between PET-CT results and MRD dynamics by intra-patient comparison. Evaluating safety, quality of life and efficacy of KRd consolidation in this population.<br>;Primary end point(s): Proportion of PET-CT positivity after standard first line treatment, and change from PET-CT positivity to PET-CT negativity after 4 cycles of KRd consolidation.;Timepoint(s) of evaluation of this end point: PET-CT will be performed at screening to assess the proportion of patients that are PET-positive after standard first line treatment.<br>Thereafter, PET-CT will be performed one month after completion of study treatment, to assess the number of PET-negative patients after 4 cycles of KRd consolidation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - MRD negativitiy by 8-colour Euroflow after 4 cycles of KRd consolidation<br>- Safety<br>- Overall response rate<br>- Progression-free survival (PFS)<br>- Time to next treatment (TTNT)<br>- Overall survival (OS)<br>- Quality of life during and after KRd consolidation;Timepoint(s) of evaluation of this end point: - MRD negativity will be evaluated one month after completed consolidation treatment.<br>- Safety will be followed from study start until 60 days after completed KRd consolidation treatment<br>- Overall response rate, progression-free survival, time to next treatment, overall survival and quality of lite will be followed throughout the study. After progressive disease the patients will be followed by telephone for overall survival. Patients with negative PET-CT results will be followed by telephone for progression-free survival and overall survival.

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