Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Part of paid clinical trials in Denver, Colorado.

Sponsor
Irene Ghobrial, MD
Study ID
NCT05469893
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • High-risk Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Smoldering Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Intravenous (IV) dosage and timing per protocol design
  • Lenalidomide — DRUG
    Oral, dosage and timing per protocol design
  • Dexamethasone — DRUG
    Oral, dosage and timing per protocol design

Study Details

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 Dates

Start date
Aug 10, 2022
Status verified
Apr 2025
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lenalidomide + Dexamethasone (LD)
    Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm * Lenalidomine * Dexamethoasone
  • Experimental: Teclistamab
    Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm \- Teclistamab-Per Protocol

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Cycle 2 Day 1 through end of follow up (each cycle is 28 days). ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218
Jeffrey Matous, MD
[email protected]
Dana Farber Cancer InstituteBostonMassachusetts02115
Irene M Ghobrial, MD
[email protected]
617-632-4198
Irene M Ghobrial, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Eva Medvedova, MD
[email protected]

Find similar trials in Denver, CO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Colorado Blood Cancer Institute· Denver, CODana Farber Cancer Institute· Boston, MAOregon Health & Science University· Portland, OR

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