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Trial record 1 of 1 for:    NCT03314636
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Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment. (CONPET)

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ClinicalTrials.gov Identifier: NCT03314636
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Nordic Myeloma Study Group
Information provided by (Responsible Party):
Fredrik Hellem Schjesvold, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Myeloma Drug: Carfilzomib Drug: Lenalidomide Device: PET-CT Drug: Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Carfilzomib

Arm Intervention/treatment
Experimental: PET-CT-positive patients
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
Drug: Carfilzomib
See in arm description

Drug: Lenalidomide
See in arm description

Device: PET-CT
See in arm description

Drug: Dexamethasone
See in arm description




Primary Outcome Measures :
  1. PET negativity after induction [ Time Frame: 1 month after induction ]
    How many of PET positive patients will become PET negative after treatment


Secondary Outcome Measures :
  1. PET correlation with MRD Euroflow [ Time Frame: 1 month after induction ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314636


Contacts
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Contact: Fredrik H Schjesvold, MD PhD +4799697796 fredrikschjesvold@gmail.com
Contact: Anna Lysén, MSc +4747246569 annaly@ous-hf.no

Locations
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Denmark
Copenhagen University Hospital, Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Annette Vangsted       annette.juul.vangsted@regionh.dk   
Odense University Hospital Not yet recruiting
Odense, Denmark
Contact: Niels Abildgaard       Niels.Abildgaard@rsyd.dk   
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Fredrik H Schjesvold, MDPhD    +4799697796    fredrikschjesvold@gmail.com   
Sweden
Skåne University Hospital Not yet recruiting
Lund, Sweden
Contact: Markus Hansson       markus.hansson@med.lu.se   
Sponsors and Collaborators
Oslo University Hospital
Nordic Myeloma Study Group

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Responsible Party: Fredrik Hellem Schjesvold, Head of Oslo Myeloma Center, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03314636    
Other Study ID Numbers: NMSG25/16
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors