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
Qualifiers
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
Treatments tested in this trial
- Teclistamab
- Lenalidomide
- Dexamethasone
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Irene Ghobrial, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Janssen Research & Development, LLC
Collaborator
Source ClinicalTrials.gov