Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Recruiting now · Phase 2

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

In brief

The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma. People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma. The names of the study drugs involved in this study are: * Teclistamab * Lenalidomide (also called Revlimid) * Dexamethasone (also called Decadron)

Key facts

Study ID

NCT05469893

Run by

Irene Ghobrial, MD

People needed

52

Starts

2022-08-10

Expected to finish

2030-07-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years.
• 1) High risk SMM defined as having 1 of the following 2 criteria: High risk per "20-2-20" Criteria defined as presence of any two of the following:
• - Serum M spike ≥ 2 gm/dL, Involved to uninvolved free light chain (FLC) ratio≥ 20, Bone marrow Plasma Cell (BMPC) % ≥ 20%
• OR total score of 9 using the following scoring system:
• FLC Ratio >10-25 = 2, >25-40 = 3, > 40 = 5
• Serum M-Protein (g/dL) >1.5-3 = 3, >3 = 4
• BMPC% >15-20 = 2, >20-30 = 3, >30-40 = 5, >40 = 6
• Fluorescence In Situ Hybridization (FISH) abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2
• 2) Presence of ≥10% BMPC and at least one of the following:
• - Evolving pattern:
• evolving Monoclonal Protein (eMP) (≥10% increase in Monoclonal Protein/Immunoglobulin (Ig)) within the first 6 months (only if M-protein ≥3 g/dl) and/or ≥25% increase in M/Ig within the first 12 months, with a minimum required increase of 0.5 g/dl in M-protein and/or 500 mg/dl in Ig.
• Evolving change in hemoglobin (eHb) ≥0.5 g/dl decrease within 12 months of diagnosis;
• Progressive involved light chain increase on two successive evaluation
• Abnormal Plasma Cell immunophenotype (≥ 95% of BMPCs are clonal) and reduction of ≥1 uninvolved immunoglobulin isotype. (Only IgG; IgA and IgM will be considered)
• High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain
• Monoclonal light chain excretion of > 200mg/24 hours for those with monoclonal light chain SMM
• No evidence of CRAB criteria* or new criteria of active MM (SLIM-CRAB) which include 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
• MRI with more than one focal lesion

You may not qualify if…

• Prior SMM directed therapy administered within 6 months of beginning treatment on study. To avoid including primary refractory cases to the lenalidomide arm, participants who received a prior lenalidomide-based therapy should have had at least an Minimal Response (MR) to be considered on this trial.
• 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 but had to be at least 6 months prior to enrollment on the trial. Prior clinical trials or therapy for smoldering MM or Monoclonal Gammopathy of Unknown Significance (MGUS) are allowed per exclusion criteria described above.
• 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
• 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.
• Plans to father a child while enrolled in this study or within 90 days after receiving the last dose of study drug.
• Pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 90 days after receiving the last dose of study drug.
• 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).
• Participants who are seropositive because of hepatitis B virus vaccine are eligible.
• Participants 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.
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab Investigator's Brochure and appropriate package inserts).
• Prior or concurrent exposure to any of the following:
• Investigational vaccine within 4 weeks
• Live, attenuated vaccine within 4 weeks before randomization.
• Monoclonal antibody therapy within 21 days
• Cytotoxic therapy within 14 days
• PI therapy within 14 days
• IMiD agent therapy within 14 days
• Radiotherapy within 14 days or focal radiation within 7 days
• A maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14-day period before the first dose of study drug (does not include pretreatment medications)
• Known active Central Nervous System (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
• Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months). The only allowed exceptions are: a. Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. c. Noninvasive cervical cancer treated within the last 24 months that is considered completely cured d. Localized prostate cancer (N0M0): With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance With a Gleason score of 3+4 that has been treated >6 months prior to full study screening and considered to have a very low risk of recurrence, or e. History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence. f. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. g. Other malignancy that is considered cured with minimal risk of recurrence
• Stroke or seizure within 6 months prior to signing informed consent form
• Presence of the following cardiac conditions:

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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