Plasma Cell Leukemia Clinical Trial
Official title:
Phase 1 Study of Daratumumab When Given in Combination With Bortezomib, Dexamethasone, Doxil, and Lenalidomide in Patients With Plasma Cell Leukemia
Verified date | December 2018 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies side effects of daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide, 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 daratumumab, bortezomib, dexamethasone, pegylated liposomal doxorubicin hydrochloride, and lenalidomide in treating participants with plasma cell leukemia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 25, 2019 |
Est. primary completion date | October 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines. - Willingness to provide bone marrow and peripheral blood samples for research purposes. If unavailable, exceptions may be granted with study principal investigator (PI) approval. - All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program and be willing to comply with its requirements. - Karnofsky performance status (KPS) > 60. - Plasma cell leukemia; either newly diagnosed or relapsed: defined as the presence of > 2 x 10^9/L peripheral blood plasma cells or plasmacytosis accounting for > 20% of the differential white cell count. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Absolute neutrophil count (ANC) >= 500/mm^3 - NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary ot disease involvement. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =< 2.0 x ULN (unless has Gilbert's disease). - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Aspartate aminotransferase (AST) =< 3.0 x ULN. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Alanine aminotransferase (ALT) =< 3.0 x ULN. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Creatinine clearance of >= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Left ventricular ejection fraction (LVEF) > 45% - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Hemoglobin >= 8.0 g/dL - Note: Transfusion support is allowed. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Seronegative for human immunodeficiency virus (HIV) antigen-antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (RPR). - If positive, hepatitis C RNA quantitation must be performed. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Meets other institutional and federal requirements for infectious disease titer requirements. - Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy. - Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. - Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. - Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only). - Women of childbearing potential must follow pregnancy testing requirements as outline in REMS program material. Exclusion Criteria: - Progression or intolerance to daratumumab, bortezomib, or lenalidomide. - Prior stem cell transplant. - Participant is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment. - Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable. - Vaccination with live attenuated vaccines within 4 weeks of first study agent administration. - Participant is currently using or has used immunosuppressive medication within 14 days prior to the first study dose of study treatment. The following are exceptions: - Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection) - Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent - Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, computed tomography [CT] scan premedication). - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent. - Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. - Has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification. - Clinically significant uncontrolled illness. - Active infection requiring intravenous antibiotics or antifungals within 14 days prior to start of study treatment. - Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection. - Grade >= 3 peripheral neuropathy, or grade >= 2 with pain on clinical examination during the screening period. - Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months. Note: Prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant. - Other active malignancy. Exceptions: Non-melanoma skin cancer, ductal breast carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix. Note: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer. Prior malignancy treated with curative intent is not an exclusion. - Females only: Pregnant or breastfeeding. - Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. - Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics). |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | City of Hope Medical Center | Duarte | California |
United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Siteman Cancer Center at Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Observed toxicities will be tabulated using frequencies and percentages based on the CTCAE v5.0. | Up to 30 days | |
Secondary | Overall response rate described by the International Myeloma Working Group (IMWG) | Response rates will also be evaluated based on number and type of prior therapy(ies); the exact binomial confidence interval (CI) will be calculated for these estimates. | Up to 18 months | |
Secondary | Duration of response | The overall response rate (ORR) will be estimated by the number of participants who achieve a confirmed response (stringent complete response [sCR]/complete response [CR]/very good partial response [VGPR] or partial response [PR]) divided by the total number of response evaluable participants. Response rates will also be evaluated based on number and type of prior therapy(ies); the exact binomial CI will be calculated for these estimates. | Up to 18 months | |
Secondary | Overall survival rate | Will be estimated using the product-limit method of Kaplan and Meier; 95% confidence intervals will be calculated using Greenwood's formula. | From date of first dose of study drug to date of death from any cause, assessed up to 18 months | |
Secondary | Progression-free survival rate | Will be estimated using the product-limit method of Kaplan and Meier; 95% confidence intervals will be calculated using Greenwood's formula. | From date of first dose of study drug to date of first documented disease relapse, progression or death from any cause, whichever occurs first, up to 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01435720 -
Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01328236 -
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
|
Phase 2 | |
Completed |
NCT02506959 -
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
|
Phase 2 | |
Not yet recruiting |
NCT05054478 -
Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation
|
Phase 2 | |
Active, not recruiting |
NCT02722668 -
UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep
|
Phase 2 | |
Recruiting |
NCT05805605 -
Allo HSCT Using RIC and PTCy for Hematological Diseases
|
Phase 2 | |
Completed |
NCT02661035 -
Allo HSCT Using RIC for Hematological Diseases
|
Phase 2 | |
Recruiting |
NCT05759793 -
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
|
Phase 1 | |
Recruiting |
NCT03314974 -
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
|
Phase 2 | |
Completed |
NCT01008462 -
Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
|
Phase 2 | |
Recruiting |
NCT05219721 -
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
|
Phase 1 | |
Completed |
NCT00307086 -
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
|
Phase 2 | |
Active, not recruiting |
NCT01729091 -
Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma
|
Phase 2 | |
Recruiting |
NCT05823571 -
Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients
|
Phase 1 | |
Recruiting |
NCT06045091 -
To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
|
Early Phase 1 | |
Recruiting |
NCT05556928 -
Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry
|
||
Completed |
NCT02504359 -
Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma
|
Phase 1 | |
Recruiting |
NCT05979363 -
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
|
Phase 2 | |
Recruiting |
NCT05283993 -
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
|
||
Recruiting |
NCT04008888 -
a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
|
N/A |