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About
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
The names of the study drugs involved in this study are:
Full description
The purpose of this research study is to learn whether the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
This combination of drugs are considered "investigational" which means it has not been approved in this combination for smoldering myeloma by the United States Food and Drug Administration.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
The names of the study drugs involved in this study are:
Participants may be treated for up to 24 months and will be followed for up to 3 years.
It is expected that about 30 people will take part in this research study.
This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone as a treatment regimen for the specific disease.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥ 18 years.
Must meet criteria of high-risk smoldering MM as described with one of the below criteria:
Bone marrow clonal plasma cells ≥10% and any one or more of the following:
OR High-risk per IMWG/Mayo 2018 "20-2-20" Criteria (at least 2 of the following)
Bone marrow plasmacytosis ≥20%
≥ 2g/dl M protein
No evidence of CRAB criteria* or new criteria of active MM which including the following:
Increased calcium levels: Corrected serum calcium >0.25 mmol/L(>1mg/dL) above the upper limit of normal or >2.75 mmol/L (>11mg/dL);
Renal insufficiency (attributable to myeloma);
Anemia (Hgb 2g/dL below the lower limit of normal or <10g/dL);
Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)
No evidence of the following new criteria for active MM including the following:
Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible after discussion with the Sponsor Investigator
ECOG Performance Status (PS) 0, 1, or 2 (Appendix A)
The following laboratory values obtained ≤ 28 days prior to registration:
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) 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 lenalidomide.
-- A female of childbearing potential is a sexually mature female who: has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)
All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
Females of child-bearing potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy
Detectable clonality sequence by next generation sequencing using clonoSEQ assay to allow for minimal residual disease measurement
Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
Symptomatic Multiple Myeloma or any evidence of CRAB criteria, including presence of myeloma defining events (MDE). Any prior therapy for active Myeloma should also be excluded. Prior therapy for smoldering myeloma is not an exclusion criterion. Bisphosphonates are not excluded
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is allowed. Prior radiation therapy to a solitary plasmacytoma is allowed. Prior clinical trials or therapy for smoldering MM or MGUS are allowed but should be discussed with the Principal Investigator.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or nursing women will be excluded from the study because lenalidomide is an agent with the potential for teratogenic or abortifacient effects.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, bortezomib, lenalidomide, or hyaluronidase
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) or SARS-CoV-2 (COVID-19).
Subject has known chronic obstructive pulmonary disease (COPD) or severe, persistent asthma with a Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal.
Primary purpose
Allocation
Interventional model
Masking
61 participants in 1 patient group
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Central trial contact
Omar Nadeem, MD
Data sourced from clinicaltrials.gov
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