Status and phase
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About
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
Exploratory Objective
Enrollment
Sex
Ages
Volunteers
Inclusion 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:
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 Medical Monitor).
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 serum or urine pregnancy test 4-14 days prior to planned start of treatment and again 24 hours prior to initiation of study medication. All FCBP must agree to either commit to continued abstinence from sexual intercourse or begin TWO acceptable methods of birth control AT THE SAME TIME, at least 28 days before receiving the first dose of STAR-LLD. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex or synthetic condom during sexual contact with a FCBP from the time of starting study treatment through 28 days after the last dose, even if they have had a vasectomy.
Able to take anti-thrombotic prophylaxis.
The following laboratory results must be met during screening:
The following criteria must be met within 72 hours prior to first administration of continuous infusion STAR-LLD:
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Central trial contact
Amy Chergey
Data sourced from clinicaltrials.gov
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