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Tests treatment safety and results for Multiple Myeloma
Official title Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
ClinicalTrials.gov ID: NCT06087653
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as bortezamib, dexamethasone.
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
- Primary Objective Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI). Secondary Objectives To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations.
- Phase 2: a mid-size study of how well it works
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
- Male or female ≥18 years at the time of informed consent.
- Autologous stem cell transplant (ASCT) ineligible.
- SARS -CoV2 virus (COVID)-19 negative.
- A prior diagnosis of MM as defined by International Myeloma Working Group (IMWG) criteria (Appendix 7).
- Documented measurable disease following first line therapy defined as:
You likely can't join if
- Pregnant or breastfeeding.
- Received an ASCT.
- Venous thromboembolism within 12 months of starting treatment on study.
- Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses.
- Currently taking any investigational therapy for the treatment of MM. A 28-day washout prior to Cycle 1 Day 1 is required for any previous...
- Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR).
See the full eligibility criteria
- Male or female ≥18 years at the time of informed consent.
- Autologous stem cell transplant (ASCT) ineligible.
- SARS -CoV2 virus (COVID)-19 negative.
- A prior diagnosis of MM as defined by International Myeloma Working Group (IMWG) criteria (Appendix 7).
- Documented measurable disease following first line therapy defined as:
- Serum monoclonal protein ≥1.0 g/dL by protein electrophoresis.
- ≥200 mg/24 hours of monoclonal protein in the urine on 24-hour electrophoresis.
- Serum free light chain (SFLC) ≥10 mg/dL AND abnormal serum kappa to lambda free light chain (FLC) ratio.
- Intended to be treated in 2nd line or greater with lenalidomide, dexamethasone, and a PI.
- Proteasome inhibitor sensitive defined as progression free for \> 6 months from cessation of PI or never received a prior PI.
- Progression per IMWG criteria on the most recent line of therapy.
- Eastern Cooperative Oncology Group (ECOG-Appendix 1) performance status ≤2 (patients with a performance status of 3 based solely on bone pain secondary to MM may be eligible following consultation and approval by the...
- Willing to comply with the protocol defined Lenalidomide Pregnancy Risk Minimization Plan for the prevention of pregnancy (Appendix 5). Females of childbearing potential (FCBP) must have a medically supervised negative...
- Able to take anti-thrombotic prophylaxis.
- The following laboratory results must be met during screening:
- ANC ≥1,000 cells/mm3 (1.0 x 109/L).
- Platelet count ≥75,000 cells/mm3 (75 x 109/L).
- Hemoglobin ≥8.0 g/dL (red blood cell (RBC) transfusions are permitted prior to initiation of study drug if hemoglobin is stable for 72 hours).
- Total bilirubin ≤1.5 x upper limit of normal (ULN), or patient diagnosed with Gilberts syndrome with a total bilirubin \<5.0 x ULN that has been reviewed and approved by the Medical Monitor.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN.
- Calculated creatinine clearance ≥60 mL/min. Appendix 4
- Negative pregnancy test for FCBP (must be obtained within 4-14 days before the initiation of study drug.
- The following criteria must be met within 72 hours prior to first administration of continuous infusion STAR-LLD:
- ANC ≥1,000 cells/mm3 (1.0 x 109/L).
- Platelet count ≥75,000 cells/mm3 (75 x 109/L).
- Hemoglobin ≥8.0 g/dL (RBC transfusions are permitted prior to initiation of study drug if hemoglobin is stable for 72 hours).
- Calculated creatinine clearance ≥60 mL/min. Appendix 4
- Negative pregnancy test for FCBP (must be obtained within 24 hours of first dose of study drug).
- Able and willing to receive percutaneous ambulatory therapy.
- Has an in-home care partner willing to receive training from a nurse for assistance with pump management.
- Pregnant or breastfeeding.
- Received an ASCT.
- Venous thromboembolism within 12 months of starting treatment on study.
- Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses.
- Currently taking any investigational therapy for the treatment of MM. A 28-day washout prior to Cycle 1 Day 1 is required for any previous investigational therapy.
- Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR).
- Discontinued a prior line of treatment due to intolerability to lenalidomide.
- Concomitant use of strong CYP3A inducers (see https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#table3-3).
- Concurrent clinically significant amyloidosis or plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Known active infection requiring systemic anti-infective treatment (prophylactic treatment is permitted).
- Prior malignancies within the previous 3 years, other than previously treated squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast or another malignancy that is considered cured...
- Prior major surgical procedure or radiation therapy within 4 weeks of the initiation of STAR-LLD (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of...
- Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the patient's safety, as per the Investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Wilson, North Carolina, United States
- Canton, Ohio, United States
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 - 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?
Study sites include Wilson, North Carolina, United States; Canton, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.