Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIrene Ghobrial, MD
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Teclistamab
DrugIntravenous (IV) dosage and timing per protocol design
Lenalidomide
DrugOral, dosage and timing per protocol design
Dexamethasone
DrugOral, dosage and timing per protocol design
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Lenalidomide + Dexamethasone (LD)Active comparator 2 interventions
Group B: TeclistamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR)
The complete response rate (CRR) was defined as the proportion of participants achieving complete response (CR) based on International Myeloma Working Group (IMWG) Response criteria. CR defined as requires all of the following: * Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks by immunofixation studies. * \<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytomas for at least six weeks.
Time frame
Cycle 2 Day 1 through end of follow up (each cycle is 28 days).Secondary outcomes
1
Minimal Residual Disease (MRD) Negativity
The MRD is expressed as a frequency that quantifies the level of residual disease based on the number of remaining copies of the initially dominant sequence(s) relative to the total number of nucleated cells in the sample.
Time frame
Baseline, Cycle 6 Day 1, Cycle 13 Day 1, end of treatment, 1, 2, & 3 year after end of treatment (each cycle is 28 day).2
Progression-free survival (PFS) until progression to myeloma
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. International Myeloma Working Group (IMWG) Response criteria: Progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Time frame
Every 6 months, up to 3 years after treatment discontinuation.3
Progression-free survival (PFS-2) post initiation of overt myeloma therapy
Progression-free survivial-2 is defined as time from randomization to disease progression (PD) while receiving overt myeloma therapy, or death from any cause.
Time frame
Every 6 months, up to 3 years after treatment discontinuation.4
Time to progression
Time to progression (TTP) is defined as the time of randomization until progression. Participants who have died without evidence of progression are censored in the TTP analysis at the time of death and participants who are alive without progression are censored at the last disease assessment.
Time frame
Cycle 2 Day1 through end of follow up, an average of 5 years (each cycle is 28 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Irene Ghobrial, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Janssen Research & Development, LLC
Collaborator
Source ClinicalTrials.gov