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

Active, enrolled Phase 2 Last updated 9 October 2024

What this trial tests

Phase 2 trial testing Daratumumab in Multiple Myeloma in 57 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 October 2020

Primary endpoint
2 May 2024

2 May 2026

Quick facts

Lead sponsor	University of Michigan Rogel Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	5 October 2020
Primary completion	2 May 2024
Estimated completion	2 May 2026
Sites	4 locations across United States

Drugs / interventions tested

• Daratumumab (daratumumab) — full drug profile →
• Lenalidomide — full drug profile →
• Bortezomib (bortezomib) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

University of Michigan Rogel Cancer Center

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Minimal Residual Disease in Multiple Myeloma: Current Landscape and Future Applications With Immunotherapeutic Approaches.
   Kostopoulos IV, Ntanasis-Stathopoulos I, Gavriatopoulou M, Tsitsilonis OE, et al · · 2020 · cited 42× · PMID 32537439 · DOI 10.3389/fonc.2020.00860
2. Measurable residual disease in multiple myeloma: ready for clinical practice?
   Burgos L, Puig N, Cedena MT, Mateos MV, et al · · 2020 · cited 32× · PMID 32571377 · DOI 10.1186/s13045-020-00911-4
3. The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
   Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
4. Minimal Residual Disease Assessment in Multiple Myeloma Patients: Minimal Disease With Maximal Implications.
   Charalampous C, Kourelis T. · · 2021 · cited 18× · PMID 35155198 · DOI 10.3389/fonc.2021.801851
5. Minimal residual disease detection by next-generation sequencing in multiple myeloma: Promise and challenges for response-adapted therapy.
   Ferla V, Antonini E, Perini T, Farina F, et al · · 2022 · cited 16× · PMID 36052251 · DOI 10.3389/fonc.2022.932852
6. Treatment Strategy for Multiple Myeloma to Improve Immunological Environment and Maintain MRD Negativity.
   Suzuki K, Nishiwaki K, Yano S. · · 2021 · cited 14× · PMID 34638353 · DOI 10.3390/cancers13194867
7. Liquid biopsies and minimal residual disease in lymphoid malignancies.
   Bou Zerdan M, Kassab J, Saba L, Haroun E, et al · · 2023 · cited 6× · PMID 37228488 · DOI 10.3389/fonc.2023.1173701
8. The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials.
   Chang E, Gittleman H, Song C, Bloomquist E, et al · · 2025 · PMID 40668757 · DOI 10.1093/jncics/pkaf069