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New treatment option for High-risk Smoldering Multiple Myeloma
Official title Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
ClinicalTrials.gov ID: NCT05469893
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-risk smoldering multiple myeloma.
Also referred to as JNJ-64007957.
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
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- 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...
- 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
You likely can't join if
- Prior SMM directed therapy administered within 6 months of beginning treatment on study. To avoid including primary refractory cases to the...
- Symptomatic Multiple Myeloma or any evidence of CRAB criteria, including presence of myeloma defining events (MDE). Any prior therapy for active...
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
- Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible after discussion with the Sponsor Investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2
- The following laboratory values obtained \<28 days prior to registration:
- Absolute Neutrophil Count (ANC) \>1000/mL
- Platelets Count (PLT) \>75,000/mL
- Total bilirubin ≤ 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.)
- Aspartates Aminotransferase (AST) \<2.5 x institutional upper limit of normal (ULN)
- Alanine Transaminase (ALT) \<2.5 x institutional upper limit of normal (ULN)
- Estimated creatinine clearance (CLcr) ≥60 mL/min
- Voluntary written informed consent will be obtained 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...
- Females of child-bearing potential\ assigned by chance to Lenalidomide 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...
- A female of child-bearing 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...
- A woman must be . A Not of childbearing potential, or b. Of childbearing potential and Practicing true abstinence; or Have a sole partner who is vasectomized; or Practicing ≥1 highly-effective, user-independent method...
- A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study treatment
- A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days...
- If the male participant is vasectomized, he still must wear a condom (with spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
- All study participants assigned by chance to lenalidomide 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 if assigned by chance to lenalidomide
- 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
- Ability to understand and the willingness to sign a written informed consent.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Stroke or seizure within 6 months prior to signing informed consent form
- Presence of the following cardiac conditions: \-- New York Heart Association stage III or IV congestive heart failure, 2) Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization,3) History...
- Major surgery within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated...
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study...
- Uncontrolled diabetes defined by Hemoglobin A1C \> 8.5, Acute diffuse infiltrative pulmonary disease, Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic, antimicrobial therapy, History...
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Boston, Massachusetts, United States
- Portland, Oregon, 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 Denver, Colorado, United States; Boston, Massachusetts, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
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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.