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

NCT04140162 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-10-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Jing Ye, M.D. · MD Anderson

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2024-05-02
Completion
2026-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04140162 on ClinicalTrials.gov