NCT04140162

Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) Sites will continue to use IV daratumumab to treat existing study patients until the IV daratumumab stock on site has been exhausted. The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab. Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1
DRUG	Lenalidomide	Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24) Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36) Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression
DRUG	Bortezomib	Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36)
DRUG	Dexamethasone	Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly

Timeline

• Start date: 2020-10-05
• Primary completion: 2024-05-02
• Completion: 2026-05-02
• First posted: 2019-10-25
• Last updated: 2024-10-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study