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

Myeloma Clinical Trial

— CONPET  

Official title:

KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03314636
• Other study ID #: NMSG25/16
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 16, 2018
• Est. completion date: November 1, 2026

Study information

• Verified date: May 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Carfilzomib
See in arm description
• Lenalidomide
See in arm description

Device:
• PET-CT
See in arm description

Drug:
• Dexamethasone
See in arm description

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Norway	Oslo University Hospital	Oslo
Sweden	Skåne University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Nordic Myeloma Study Group

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET negativity after induction	How many of PET positive patients will become PET negative after treatment	1 month after induction
Secondary	PET correlation with MRD Euroflow	Before intervention all patients are PET-CT positive. The investigators will measure minimal residual disease (MRD) with immuno-flow cytometry, at the same timepoint, and describe how many of the PET-CT patients, are MRD-negative and how many are MRD-positive. After the intervention the investigators will again do PET-CT and MRD by flow cytometry. The investigators will then describe how many PET-positive patients are MRD-positive and how many are MRD-negative. As well, the investigators will describe the same in the PET-CT negative patients.	1 month after induction