MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma
ConditionMultiple Myeloma (MM)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Arkansas
About this trial
The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of PD requiring initiation of treatment.
Patients must be either untreated or have not received more than two months of MM therapy. However, bisphosphonates and localized radiation are allowed.
High-risk cytogenetic abnormalities, including t(4;14), t(14;16), t(14;20), del17p13, del1p, or gain 1q with del1p by FISH, with a cutoff point of 20% or greater.
Beta-2-microglobulin >5.5 mg/L with normal kidney function test per the institutional reference.
Disqualifiers
Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, low Gleason score prostate cancer on active surveillance or having had surgery/radiation with curative intent within one year of consent or other cancer for which the patient has not received treatment for one year prior to consent. Other cancers will only be acceptable if the patient's life expectancy exceeds five years.
Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Or subject is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Women of childbearing potential (WOCBP) must have a negative pregnancy documented within one week of consent. Subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and patients must be excluded if FEV1 is <50% of predicted normal.
Trial design
Design model
Parallel
Treatments tested in this trial
teclistamab+daratumumab followed by talquetamab+daratumumab followed by duration treatment with daratumumab and lenalidomide extended/maintenance
Drugteclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.
melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by drug therapy
Procedure/SurgerySubjects who are MRD-positive (a threshold of 10\^5) will receive a single melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by a 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: MRD-negativeExperimental treatment 1 intervention
Group B: MRD-positiveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR) in subjects with high-risk multiple myeloma (HRMM) treated with the sequential use of Bispecific Antibodies.
to determine the Complete Response Rate (CRR), defined as the proportion of subjects achieving complete response (CR) or stringent complete response (sCR) according to IMWG criteria at the 'Pre-Maintenance' timepoint (after completion of Immunotherapy #4, Cycle 4)
Time frame
Up to 4 years2
the 2-year Progression-Free Survival (PFS) percentage in subjects with high-risk multiple myeloma (HRMM) treated with the sequential use of Bispecific Antibodies.
determine the 2-year Progression-Free Survival (PFS) percentage in subjects with high-risk multiple myeloma (HRMM) treated with the sequential use of bispecific antibodies.
Time frame
2 years after study completionSecondary outcomes
1
evaluate the Minimal Residual Disease (MRD) Negativity Rate (MRDNR) in subjects with HRMM treated with the sequential use of Bispecific Antibodies.
to evaluate the Minimal Residual Disease (MRD) Negativity Rate (MRDNR) in subjects with high-risk multiple myeloma (HRMM) treated with the sequential use of bispecific antibodies. MRDNR will be determined using FDA-approved clonoSEQ NGS assessment at a threshold of 10\^6.
Time frame
Up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arkansas
Lead sponsor
Janssen Research & Development, LLC
Collaborator
Source ClinicalTrials.gov
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