Treament of multiple myeloma

A phase II multicenter, randomized controlled trial comparing a generic triplet combination of Bortezomib-Pomalidomide-Dexamethasone vs Bortezomib-Lenalidomide â??Dexamethasone in patients with newly diagnosed multiple myeloma - Not applicable

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021385

Enrollment

100

Registered

2019-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Bortezomib- Pomalidomide and Dexamethasone (VPD): Inj. Bortezomib- 1.3mg/m2 on day1,8,15,22 x subcute x stat Cap.Pomalidomide - 4mg x od x pox 21/28 Tab. Dexamethasone-40mg x od x po x

Eligibility

Inclusion criteria

Inclusion criteria: a)Newly diagnosed patients with multiple myeloma b)Age between 18-60years

Exclusion criteria

Exclusion criteria: a)Creatinine clearance b)Venous thromboembolism at diagnosis c)Past history of venous thromboembolism d)Hepatic dysfunction â?? Bil > 2, AST/ALT >4 times ULN e)Grade 3-4 peripheral neuropathy f)Pregnancy g)Not able to understand the investigative nature of the study or give consent

Design outcomes

Primary

Measure	Time frame
a. Complete response after 4 cycles of therapy Timepoint: 4 months	—

Secondary

Measure	Time frame
a.Overall response rates after 4 cycles b.MRD (minimal residual disease) negativity after 4 cycles c.Three-year event free survival d.Three-year overall survival e.The incidence of grade 3 and 4 adverse events Timepoint: 4 months	—

Countries

India

Contacts

Public ContactAnup Devasia

Christian Medical College, Vellore

dranupjdevasia@gmail.com04162282352

Outcome results

None listed

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