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Efficacy of Bortezomib, Lenalidomide and Dexamethasone combination therapy after Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma patients

â??Bortezomib, Lenalidomide and Dexamethasone based consolidation therapy after Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma: A single arm prospective studyâ??

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008741
Enrollment
93
Registered
2017-06-02
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: null- Patients with multiple myeloma post autologous hematopoeitic stem cell transplatation

Interventions

Intervention1: Bortezomib Lenalidomide Dexamethasone: 1.Inj. Bortezomib 2 mg s/c (to be diluted in 1.5 ml normal saline) weekly doses (d1,d8,d15,d22) 2.Cap. Lenalidomide 15mg Per Oral daily for 15 da

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All multiple myeloma patients who have undergone Autologous Hematopoietic stem cell transplant will be enrolled at 100 days (± 2weeks) of post ASCT

Exclusion criteria

Exclusion criteria: 1. ECOG Performance status 3 and 4 2. Uncontrolled diabetes and hypertension 3. peripheral neuropathy > grade 2 4. Any contraindication to anticoagulant prophylaxis 5. Persistent cytopenias >=1 cell line (Hb

Design outcomes

Primary

MeasureTime frame
To assess response rate after post Autologous Hematopoietic Stem ceell transplantation consolidation therapyTimepoint: 1ST August, 2016 to 31st May, 2018

Secondary

MeasureTime frame
1.To assess for MRD negativity rate post consolidation therapy 2.To assess for one year PFS 3.To assess for toxicity of consolidation therapy Timepoint: 1ST August, 2016 to 31st May, 2018

Countries

India

Contacts

Public ContactDr Patekar Mukesh Bhimrao

All India Institute of Medical Sciences

lalitaiims@yahoo.com01126863405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026