Clinical trial for Smoldering Plasma Cell Myeloma
Official title Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma
ClinicalTrials.gov ID: NCT03937635
What this study is testing
What is Daratumumab?
An investigational intravenous monoclonal antibody being studied for high‑risk smoldering multiple myeloma. It is designed to target CD38 on plasma cells to help the immune system attack cancer cells.
Also referred to as Darzalex.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether the combination of lenalidomide, dexamethasone, and daratumumab is more effective than lenalidomide and dexamethasone alone in slowing or stopping the growth of high‑risk smoldering myeloma cells.
- Who it's for
- Adults with high‑risk smoldering plasma cell myeloma.
- What's involved
- Participants will receive either lenalidomide and dexamethasone alone or the same drugs plus daratumumab, with regular clinic visits and blood tests to monitor treatment and side effects.
- Time commitment
- The trial lasts about 2 years, with frequent visits during the first months and then regular follow‑up appointments every few months.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Abnormal serum free light chain ratio of involved to uninvolved \>20, but less than 100 if the involved FLC is \>= 10 mg/dL by serum free light chain...
- Serum M-protein level \>= 2 gm/dL
- Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
- \>20% plasma cells on biopsy or aspirate
- Bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
See the full eligibility criteria
- Abnormal serum free light chain ratio of involved to uninvolved \>20, but less than 100 if the involved FLC is \>= 10 mg/dL by serum free light chain (FLC) assay
- Serum M-protein level \>= 2 gm/dL
- Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
- \>20% plasma cells on biopsy or aspirate
- Bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
- \>= 1 g/dL on serum protein electrophoresis (within 28 days prior to randomization).
- \>= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization).
- NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted.
- SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization.
- NOTE: UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is \>= 200 mg/24 hour (hr), and urine in addition to serum must be...
- Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., \> 11 mg/dL or 1mg/dL above upper limit of normal [ULN]).
- Hemoglobin \>= 11 g/dL (within 28 days prior to randomization).
- Platelet count \>= 100,000 cells/mm\^3 (within 28 days prior to randomization).
- Absolute neutrophil count \>= 1500 cells/mm\^3 (within 28 days prior to randomization).
- Calculated creatinine clearance \>= 30 mL/min (within 28 days prior to randomization).
- Bilirubin =\< 1.5 mg/dL (within 28 days prior to randomization).
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =\< 2.5 times the upper limit of normal (within 28 days...
- Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis/aspirin.
- Patients must not have more than one focal marrow lesion on magnetic resonance imaging (MRI) of either pelvis or spine.
- Concurrent use of erythropoietin is not allowed while on study therapy.
- Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted. Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted
- Patients must not have active, uncontrolled seizure disorder. Patients must not have had a seizure in the last 6 months.
- Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or...
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Patients with monoclonal gammopathy of undetermined significance are not eligible.
- Patients must not have grade 2 or higher peripheral neuropathy per CTCAE.
- Patients must not have active, uncontrolled infection.
- Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
- Patients should not have New York Heart Association classification III or IV heart failure at baseline.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer.
- Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of REMS.
- Women must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25...
- Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective...
- Human immunodeficiency virus (HIV)+ patients with undetectable HIV viral loads tested within 6 months are eligible.
- Patients should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
- Patients must not have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal or known moderate or severe persistent asthma within 2 years prior...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Goodyear, Arizona, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Arroyo Grande, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Martinez, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Luis Obispo, California, United States
- Santa Maria, California, United States
- Stockton, California, United States
- Walnut Creek, California, United States
- Woodland, California, United States
- Aurora, Colorado, United States
- Boulder, Colorado, United States
+ 340 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anchorage, Alaska, United States; Goodyear, Arizona, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States and 354 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.