Loading clinical trials...

Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma

Maintenance Therapy With Carfilzomib, Pomalidomide and Dexamethasone (CPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In

NCT03756896•Emory University

View on ClinicalTrials.gov

Summary

This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma.

Detailed Description

PRIMARY OBJECTIVE: I. To determine the ≥ complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance. SECONDARY OBJECTIVES: I. To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients. II. To determine the best response rates (very good partial response rate \[VGPR\], stringent complete response \[sCR\] rate) with CPd maintenance. II. To evaluate the safety of the CPd combination as maintenance regimen. III. To characterize safety in subjects who receive CPd maintenance. IV. To evaluate the duration of response (DOR). V. To evaluate the overall survival (OS) in high-risk patients. VI. To evaluate the minimal residual disease (MRD) detection with CPd maintenance. OUTLINE: Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion, willing and able to comply with the protocol requirements
•Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
•Subject is a transplant-eligible patient that have undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and have achieved ≥ partial response (PR) based on International Myeloma Working Group (IMWG) standard criteria
•Patients with high risk disease defined as
•* Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG)
•* Plasma cell leukemia at diagnosis with ≥ 20% circulating plasma cells on peripheral blood
•Subject agrees to refrain from blood donations during therapy on study and for 90 days after therapy is completed
•Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International units (mIU)/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of study drug; all patients must be registered in and must comply with all requirements of the pomalidomide Risk Evaluation and Mitigation Strategies (REMS) program; male subjects should refrain from sperm donation for at least 90 days after the last dose of carfilzomib or pomalidomide
•* FCBP refers to sexually mature female, regardless of sexual orientation or whether they have undergone tubal ligation, who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months

Exclusion Criteria

•Diagnosed with smoldering multiple myeloma (MM), monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or standard risk myeloma or secondary plasma cell leukemia
•High risk patients that did not achieve ≥ PR after stem cell transplant
•Participant has ≥ grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
•Creatinine clearance \< 30 mL/min (either actual or calculated value), within 21 days of initiation of protocol therapy; the Cockcroft-Gault formula should be used for calculating creatinine clearance values
•Platelet count \< 75,000 cells/mm³ at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
•Participants with an absolute neutrophil count (ANC) \< 1000 cells/mm³ at time of screening evaluation; growth factors may not be used to meet ANC eligibility criteria within 14 days of obtaining screening evaluation
•Participants with hemoglobin level \< 8.0 g/dL, at time of screening; transfusion may not be used to meet eligibility criteria within 7 days of obtaining screening evaluation
•Bilirubin \> 1.5 x institutional upper limit of normal (ULN), within 21 days of initiation of protocol therapy
•Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]), or alkaline phosphatase \> 3 x institutional ULN, within 21 days of initiation of protocol therapy
•Other ongoing or prior anti-myeloma therapy; patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. once daily \[q.d.\] or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment)
+17 more criteria

Locations (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Key Dates

Start Date

January 25, 2019

Primary Completion Date

June 24, 2025

Completion Date

June 30, 2026

Last Updated

April 30, 2025

Enrollment

ACTUAL participants

Conditions

Plasma Cell Myeloma

Interventions

Carfilzomib

DRUG

Dexamethasone

DRUG

Pomalidomide

DRUG

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

NCT06356571

Plasma Cell Myeloma Refractory

View study

RECRUITING

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

NCT05334069

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia+60 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant

Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma