Home-Based Subcutaneous Bortezomib for Patients with Multiple Myeloma and Amyloidosis

A Phase II Prospective clinical trial in patients with Multiple Myeloma and Amyloidosis: Evaluating Feasibility of home Administered Subcutaneous Bortezomib Injections. - SABIMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079150

Enrollment

Registered

2025-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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: home-administered subcutaneous Bortezomib injections.: The intervention in this study would be home-administered subcutaneous Bortezomib injections. Typically, Bortezomib is given intra

Eligibility

Inclusion criteria

Inclusion criteria: Patient diagnosed with Multiple Myeloma and Amyloidosis (Confirmed with : Bone marrow biopsy, blood reports?) At baseline normal hematological parameters : 1. Absolute neutrophil count (ANC) = 1.5 × 10 ? /L, 2. Platelet count = 100 ×10 ? /L, and 3. Hemoglobin = 8 g/dL (may have been transfused) Patient willing to give consent.

Exclusion criteria

Exclusion criteria: Pregnant or nursing woman. Inability to understand the written and verbal instructions. Not willing for follow-up as per the protocol. Skin disease hampering subcutaneous administration Seropositivity for HIV, HBsAg or HCV.

Design outcomes

Primary

Measure	Time frame
Variables to be estimated Percentage of patients with self administer bortezomib and incidence of grade 3 or more side effectsTimepoint: 2 years	—

Secondary

Measure	Time frame
To assess the safety(Grade 3 side effects) over the course of study.Timepoint: 2 years	—

Countries

India

Contacts

Public ContactDr Bhausaheb Bagal

Tata Memorial Centre

bagalbp@gmail.com02224177210

Outcome results

None listed

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