DARA RVD For High Risk SMM

Running, not enrolling · Phase 2

Conditions studied: High-risk Smoldering Multiple Myeloma, Multiple Myeloma

In brief

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: * Daratumumab (also called Darzalex Faspro) * Bortezomib (also called Velcade) * Lenalidomide (also called Revlimid) * Dexamethasone

Key facts

Study ID

NCT04775550

Run by

Omar Nadeem, MD

People needed

61

Starts

2021-03-08

Expected to finish

2030-12-08

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Serum M protein ≥3.0 gm/dL
• Immunoparesis with reduction of two uninvolved immunoglobulin isotypes
• Serum involved/uninvolved free light chain ratio ≥8 (but less than 100)
• Free Light Chain Smoldering Myeloma patients are not excluded
• Progressive increase in M protein level (Evolving type of SMM)*** Increase in serum monoclonal protein by ≥10% on two successive evaluations within a 6-month period
• Bone marrow clonal plasma cells 50-60%
• Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes
• High Risk FISH defined as any one or several of the following: t(4;14), t(14;16), t(14;20), del 17p or 1q gain
• MRI with diffuse abnormalities or 1 focal lesion (≥5mm)
• PET-CT with one focal lesion (≥5mm) with increased uptake without underlying osteolytic bone destruction
• 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
• 20 involved: uninvolved serum free light chain ratio
• 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:
• Bone marrow plasma cells >60%
• Serum involved/uninvolved FLC ratio ≥100

You may not qualify if…

• 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).
• Patients who are seropositive because of hepatitis B virus vaccine are eligible.
• Patients who are positive for SARS-COV-2 antibody, HIV1 and 2 antibody, hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
• 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.
• Note that PFT/FEV1 testing is required at screening for patients suspected of having COPD or severe, persistent asthma or are suspected of having those conditions or other respiratory impairment

Where it is running

• Stamford Hospital — Stamford, Connecticut, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Brigham Cancer Center - Foxborough — Foxborough, Massachusetts, United States
• Dana-Farber Cancer Institute - Merrimack Valley — Methuen, Massachusetts, United States
• Dana-Farber Brigham Cancer Center — South Weymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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