Treament of multiple myeloma

Phase 2

Recruiting

• Conditions: Other specified diseases of bloodand blood-forming organs,

• Registration Number: CTRI/2019/09/021385
• Lead Sponsor: Christian Medical College Vellore

Brief Summary

Newly diagnosed patients with multiple myeloma who areeligible for the study will be randomized into 2 arms. Patients in the firstarm will be given a triplet induction – VPD(Bortezomib-Pomalidomide-Dexamethasone) for 4 cycles. Transplant eligiblepatients would undergo an autologous stem cell transplantation after 4 cyclesand post transplantation would be started on Pomalidomide as maintenance whichwill be continued for 2 years. Transplant ineligible patients will be put onPomalidomide maintenance for 2 years.

Patients in the second arm will be given a triplet induction –VLD (Bortezomib-lenalidomide-Dexamethasone) for 4 cycles. Transplant eligiblepatients would undergo an autologous stem cell transplantation after 4 cyclesand post transplantation would be started on lenalidomide as maintenance whichwill be continued for 2 years. Transplant ineligible patients will be put onLenalidomide maintenance for 2 years.

Patients in these 2 groups will be followed up for a minimumof 3 years and will be compared for difference in achievement of completeresponse after 4 cycles of induction, event free survival, overall survival,time to next therapy and complications.

**Introduction:** A triplet based induction regimen containing aproteasome inhibitor and an immunomodulatory is considered the standard of careinduction regimen for newly diagnosed patients with multiple myeloma.Pomalidomide is the newest immunomodulatory agent and has shown significantanti-myeloma activity and response rates in relapsed and refractory myeloma.However, Pomalidomide has never been tried in the upfront treatment of multiplemyeloma.

**Aims and objectives:** To compare the effect of a tripletcombination of Bortezomib-Pomalidomide-Dexamethasone vs Bortezomib-Lenalidomide–Dexamethasone in patients with newly diagnosed multiple myeloma.

**Methodology:** Eligible patients newly diagnosed multiplemyeloma patients will be randomly assigned into 2 groups.  One group will receive a triplet regimencontaining Bortezomib- Pomalidomide and Dexamethasone (VPD). The other group willreceive Bortezomib-lenalidomide-Dexamethasone (VLD) regimen. The patients inthe 2 groups will be analyzed for clinical response at the end of 4 cycles.

At the end of 4 cycles, if patients attain more than very goodpartial response, all transplant eligible patients would be offered anautologous stem cell transplantation. In either of the groups, patientsundergoing the autologous stem cell harvest would be given maintenance with theimmunomodulatory (Pomalidomide or Lenalidomide) given during induction. Theenrollment will be for 2 years.  Allpatients will be followed up for a minimum period of 3 years and they will beevaluated for 3-year event free survival, overall survival, and grade 3 and 4 toxicity.

Each centre will recruit 40-50 patients for this study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-09-24
• Study Start: 2019-09-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

a)Newly diagnosed patients with multiple myeloma b)Age between 18-60years.

Exclusion Criteria

a)Creatinine clearance <30 or patients on dialysis b)Venous thromboembolism at diagnosis c)Past history of venous thromboembolism d)Hepatic dysfunction – 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Complete response after 4 cycles of therapy	4 months

Secondary Outcome Measures

Name	Time	Method
a.Overall response rates after 4 cycles	b.MRD (minimal residual disease) negativity after 4 cycles

Trial Locations

Locations (1)

Christian Medical College, Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College, Vellore

🇮🇳Vellore, TAMIL NADU, India

Anup J Devasia

Principal investigator

04162282352

dranupjdevasia@gmail.com