Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma With Carfilzomib Lenalidomide Dexamethasone

NCT03375567 | Completed DMC

• 1 other identifier: 2000021421
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the detection rate of residual/refractory disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after induction therapy with carfilzomib, lenalidomide and dexamethasone regimen.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Detection rate of residual/refractory

  The purpose of this outcome is to compare standard biopsy procedures with the image guided approach. International Myeloma Working Group (IMWG) Criteria for Response and Progression standards will be used to determine the detection rate of residual/refractory.

  4 months

Secondary Outcomes (2)

• Myeloma lesion response rate

  4 months

• Overall clinical response rate

  4 months

Study Arms (2)

Guided Lesion Biopsies

EXPERIMENTAL

After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.

Procedure: Guided Lesion Biopsies

Standard Lesion Biopsies

ACTIVE COMPARATOR

After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.

Procedure: Standard Lesion Biopsies

Interventions

Guided Lesion Biopsies PROCEDURE

After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.

Guided Lesion Biopsies

Standard Lesion Biopsies PROCEDURE

After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.

Standard Lesion Biopsies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be diagnosed with symptomatic multiple myeloma within 90 days prior to registration
• Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 35 days prior to randomization:
• Detectable monoclonal protein (M-protein) on serum protein electrophoresis
• Detectable monoclonal protein on a 24 hour urine protein electrophoresis
• Abnormal serum kappa to lambda free light chain ratio (\< 0.26 or \> 1.65)
• Clonal bone marrow plasma cells ≥10%
• Myeloma-defining bone lesion or extramedullary plasmacytoma on advanced imaging
• The following laboratory values must be obtained within 35 days prior to registration:
• Hemoglobin ≥ 7 g/dL
• Platelet count ≥ 50,000 cells/mm3
• Absolute neutrophil count ≥ 500 cells/mm3
• Calculated creatinine clearance ≥ 15 mL/min
• Bilirubin ≤ 2 mg/dL
• SGPT (ALT) and SGOT (AST) \< 3 times the upper limit of normal. (Red blood cell and platelets transfusion is allowed to maintain the above goal) Patients may have received one cycle (28 days or less) of prior chemotherapy and no more than 320mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. They may have received lenalidomide, bortezomib, or cyclophosphamide for treatment of symptomatic myeloma. They may not have received prior carfilzomib.
• Prior radiation therapy to symptomatic lesions is allowed provided 10 days is allowed between the completion of radiation therapy and start of protocol treatment.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Natalia Neparidze, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: June 4, 2018
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

US (1)