Health TrialsbyHealthPanel

ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (ADVANCE 2.0)

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Serum monoclonal protein ≥ 1.0 g/dL

Urine monoclonal protein ≥ 200 mg/24 hour

Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal kappa/lambda ratio

Patients who have evaluable disease based on samples other than urine do not need to have urine evaluated for initial or subsequent response assessments.

Disqualifiers

Adult male and female participants ≥ 18 years of age.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Refer to Appendix A)

Absolute neutrophil count (ANC) >1.0 K cells/μL; At the discretion of the Investigator, patients with an ANC of 0.5 K/μL-1.0 K/μL may also be enrolled if clinically appropriate (eg, patients with a baseline neutropenia that is chronic and/or ethnic neutropenia and that does not cause complications, e.g, no history of chronic infections).

Platelet count >75 K cells/μL

Trial design

Design model

Single group

Treatments tested in this trial

  • Lenalidomide

    Drug

    Participants will receive 25mg of Lenalidomide orally on Days 2-21 of Cycle 1, then 25 mg by mouth on Days 1-21 of the remaining cycles.

  • Dexamethasone

    Drug

    Participants will receive 20mg of Dexamethasone orally on Days 1, 3, 8, and 15 of Cycle 1, then 4mg orally on Days 1 and 15 of Cycles 4-6.

  • Elranatamab

    Drug

    Participants will receive 12mg Elranatamab subcutaneous (SC) on Cycle 1; 32mg subcutaneous (SC) on Cycle 1 Day 3; 76mg subcutaneous (SC) on Cycle 1 Day 8 and Day 15. Then, participants will receive 76mg subcutaneous (SC) on Days 1 and 15 of Cycles 2-6. Lastly, participants will receive Elranatamab subcutaneous (SC) on Day 1 of the remaining cycles.

Treatment groups

104 Participants
are divided into 1 treatment group
Group A: Elranatamab in combination with lenalidomide and dexamethasone (ERd)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Minimal residual disease (MRD) (10^-5 sensitivity)

Minimal residual disease (MRD) is defined as 0 residual clonal cells in a bone marrow biopsy sample MRD negativity (10\^-5 sensitivity) after 12 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment.

Time frame
Up to 2 years

Secondary outcomes

1

Best Overall Response

The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Will be measured during the first 12 and 24 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment. Will be measured in months.

Time frame
Up to 24 months
2

Sustained MRD Negativity

The sustained rate of MRD-negativity among participants will be reported. The duration of time in months measured from the first time the participant achieves an MRD-negative bone marrow (BM) biopsy result until the time the participant has relapsed from MRD-negativity objectively documented with an MRD-positive BM result.

Time frame
Up to 2 years
3

Minimal residual disease (MRD) (10^-6 sensitivity)

Minimal residual disease (MRD) negativity ( 10\^-6 sensitivity) is defined as 0 residual clonal cells in a bone marrow biopsy anytime in the first 24 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment.

Time frame
Up to 2 years
4

Progression-Free Survival (PFS)

Progression-free survival (PFS) among study participants will be assessed during treatment and clinical follow-up. PFS is defined as the time in months from start of treatment until disease progression or death.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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