Less doses of daratumumab are adequate to achieve response in newly diagnosed multiple myeloma

Less is Adequate A Phase 2 study of Less Frequent Dosing of Daratumumab in Newly diagnosed Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087866

Enrollment

Registered

2025-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C900- Multiple myeloma

Interventions

Intervention1: Daratumumab (DARA) with VRd (bortezomib lenalidomide and dexamethasone) (DARA VRD ): In each Dara-VRd cycle , Daratumumab will be administered at a dose 16 mg/kg intravenously (Day 1,Da

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed multiple myeloma 2. ECOG performance status 0 to 2 3. Acceptable liver functions, as specified below: Total bilirubin less than 2 times upper limit of normal ULN , Aspartate transaminase AST,SGOT, alanine transaminase ALT,SGPT less than 3 ULN 4. Acceptable hematological parameters: Hemoglobin more than 7g per dl, Absolute neutrophil count ANC more than or equal to 500 pe rmm3, platelet count more than or equal to 50,000 per mm3 5. Creatinine clearance more than or equal to 30 ml per minute by Cockgroft Gault formula 6. Treatment na ve or received less than or equal to 1 cycle less than or equal to 28 days of bortezomib based triplet therapy

Exclusion criteria

Exclusion criteria: 1. Other plasma cell dyscrasias Plasma cell leukemia more than or equal to 5 percent circulating plasma cells in peripheral blood, AL Amyloidosis, POEMS syndrome 2. Patients with symptomatic central nervous system involvement as per assessing clinician 3. Patients with symptomatic obstructive airway disease, as per assessing clinician 4. New York Heart Association NYHA Class III or IV cardiac disease, or left ventricular ejection fraction less than 40 percent 5. Human immunodeficiency virus HIV positive or HBsAg positive 6. Pregnant or breastfeeding female

Design outcomes

Primary

Measure	Time frame
Post-induction MRD negativity rate, defined as the proportion of subjects who achieve MRD negativity (at or below the threshold of 10-5) at the end of 4 cycles of inductionTimepoint: 16 weeks	—

Secondary

Measure	Time frame
1. To determine if modified daratumumab schedule when added to VRd will improve the clinical outcome as measured by Response rate Overall response rate ORR, and more than equal to CR rate after 4 cycles post induction Response rate ORR, and more than equal to CR rate at day 90 plus minus 10 days post ASCT 2. 2 year PFS rate 3. To assess the safety profile of modified daratumumab schedule plus VRd protocol 4. To assess MRD negativity at day 90 plus minus 10 days post ASCT in patients who undergo ASCT 5. To evaluate pharmacokinetics pK of daratumumab 6. To evaluate stem-cell yield after mobilization 7.To evaluate time to engraftment post ASCT Timepoint: 5 years	—

Measure

Time frame

1. To determine if modified daratumumab schedule when added to VRd will improve the clinical outcome as measured by Response rate Overall response rate ORR, and more than equal to CR rate after 4 cycles post induction Response rate ORR, and more than equal to CR rate at day 90 plus minus 10 days post ASCT 2. 2 year PFS rate 3. To assess the safety profile of modified daratumumab schedule plus VRd protocol 4. To assess MRD negativity at day 90 plus minus 10 days post ASCT in patients who undergo ASCT 5. To evaluate pharmacokinetics pK of daratumumab 6. To evaluate stem-cell yield after mobilization 7.To evaluate time to engraftment post ASCT Timepoint: 5 years

—

Countries

India

Contacts

Public ContactDr Sumeet Mirgh

Tata Memorial Centre ACTREC (Advanced Centre for Treatment, Research and Education in Cancer)

drsumeetmirgh@gmail.com8130140245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026