Effectiveness of prednisolone in treatment of multiple myeloma

Evalute and compare the effectiveness of oral thalidomide + Bortezomib (subcutaneous) + Dexamethasone(IV) regimen with Bortezomib (subcutaneous) + oral prednisolone + oral thalidomide regimen in patients with newly diagnosed multiple myeloma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017032633143N1

Enrollment

Registered

2017-09-17

Start date

2017-04-03

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

multiple myeloma. Multiple myeloma

Interventions

Intervention 1: Inervention group Tab prednisolone 100 mg on day 1 to 4th and day 8 to eleventh in the form of orally administered for 4 (21-day) cycles. Intervention 2: Control group by intravenous

Treatment - Drugs

Inervention group Tab prednisolone 100 mg on day 1 to 4th and day 8 to eleventh in the form of orally administered for 4 (21-day) cycles

Control group by intravenous dexamethasone 40 mg on days 1, 4, 8 and 11 administered for 4 (21-day) cycles

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Newly diagnosed patients with multiple myeloma who have over 18 years of age and are willing to participate in this study. Exclusion criteria: HIV-positive patients, patients with a history of malignant, uncontrolled diabetes, neuropathy grade 2 diabetes, significant liver and kidney and heart failure are excluded.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Effectiveness. Timepoint: After 4 courses of treatment. Method of measurement: Check list and interviews.;Side effects. Timepoint: After 4 courses of treatment. Method of measurement: Check list and interviews.	—

Secondary

Measure	Time frame
Plt changes. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;Neuropathy. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;The cost of treatment. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;WBC changes. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;The number of pack cell. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;Quality of Life. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.	—

Measure

Time frame

Plt changes. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;Neuropathy. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;The cost of treatment. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;WBC changes. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;The number of pack cell. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.;Quality of Life. Timepoint: After 4 courses of treatment. Method of measurement: check list and interviews.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadamir Sarabi

Tehran University of Medical Sciences

drsam_amir@yahoo.com; msarabi@razi.tums.ac.ir+98 21 8800 1382

Outcome results

None listed

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