Condition category
Cancer
Date applied
31/10/2019
Date assigned
08/11/2019
Last edited
11/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Multiple myeloma is a clonal plasma cell malignancy that accounts for slightly more than 10% of all hematologic cancers. The therapy varies from chemotherapy, autologous bone marrow transplant, to novel agents . Chemotherapy for myeloma with Melphalan and prednisone produces an objective response in 50–60% of patients.

Curcumin is a natural polyphenol compound derived from turmeric (Curcuma longa). A number of preclinical studies have demonstrated that curcumin has anticancer effects against a variety of tumors, myeloma, both in vitro and in vivo. The safety of curcumin has been approved by the Food and Drug Administration and World Health Organization; In addition, its safety is strongly supported by the fact that this agent has been used in traditional Indonesia, India and Chinese medicine
The primary outcome of this study was to prove the efficacy of curcumin in the improvement of the remission status in myeloma patient. The secondary outcome was to evaluate the effect of curcumin to various disease activity, including NF-κB, IL-6, VEGF, TNF-α, CRP, and LDH.

Who can participate?
Multiple myeloma patients aged over 18 years who are ineligible for transplant

What does the study involve?
Patients will be randomly allocated to receive chemotherapy alone or chemotherapy plus curcumin for four 28 day cycles.

What are the possible benefits and risks of participating?
If the administration of curcumin can improve remission in the sample population, it certainly can be proposed as a useful complementary therapy

Where is the study run from?
Dr Kariadi General Hospital, Indonesia

When is the study starting and how long is it expected to run for?
February 2016 to February 2017

Who is funding the study?
LPDP (Lembaga Pengelola Dana Pendidikan), Indonesia

Who is the main contact?
Dr Damai Santosa
santosaivha@fk.undip.ac.id

Trial website

Contact information

Type

Scientific

Primary contact

Dr Damai Santosa

ORCID ID

https://orcid.org/0000-0002-6093-5049

Contact details

Jl. Dr. Sutomo no 16
Semarang
3374010
Indonesia
+6281325062592
santosaivha@fk.undip.ac.id

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3000113510022

Study information

Scientific title

The effect of curcumin on remission status and survival on myeloma patients treated with melphalan prednisone: a pilot randomized clinical trial

Acronym

Study hypothesis

1. The addition of curcumin to treatment will increase overall remission in myeloma patients treated with melphalan prednisone
2. The addition of curcumin to treatment will decrease measures of NF-κB, IL-6, VEGF, TNF-α, CRP, and LDH in myeloma patients treated with melphalan prednisone

Ethics approval

Approved 17/02/2016, Komisi Etik Penelitian Kesehatan (Jl. Dr. Soetomo No18, Semarang City, Central Java Province, Indonesia, 50244; +62243818550), ref: 16/EC/FK-RSDK/I/2016

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (in Indonesian)

Condition

Multiple myeloma

Intervention

Patients were allocated randomly in two parallel study groups using a sealed envelope method. The treatment group (17 patients) was treated with MP regimen (melphalan 4mg/m², prednisone 40mg/m², for 7 days) and curcumin 8 grams/daily for 28 days. The control group (16 patients) was treated with MP regimen and placebo. All of the patients were evaluated every 28 days for a total of 4 cycles treatment.

Each patient was followed up every 28 days, for 4 cycles. A checklist was used for data collection and filled in each visit separately. The contents of checklist were the patients' profiles (age, sex, education level), and laboratory data, including full blood count (FBC), urea, creatinine, NF-kB, IL-6, CRP, LDH, VEGF, and patient group (treatment or control). The physical exam of the patients was performed by a physician every visit (single blindness). Remission and TNF-a was evaluated after the end of study

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Overall remission at the end of the study period

Secondary outcome measures

Levels of NF-kB, TNF-a, VEGF, IL-6, CRP, LDH measured using blood test every 28 days throughout the study period

Overall trial start date

29/09/2015

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. New multiple myeloma patients
2. Aged over 18 years old
3. Ineligible for transplant

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 participants, 10 in each group

Participant exclusion criteria

1. Sepsis
2. Severe infection
3. Pregnancy
4. Patients with severe disease (such as acute hepatitis, chronic hepatitis, cirrhosis)
5. Elevation of aspartate aminotransferase (AST) >3 times upper limit normal (ULN)
6. Participated in another study
7. Poor performance status

Recruitment start date

01/02/2016

Recruitment end date

01/05/2017

Locations

Countries of recruitment

Indonesia

Trial participating centre

dr. Kariadi General Hospital
Jl. Dr. Sutomo no 16
Semarang
3374010
Indonesia

Sponsor information

Organisation

LPDP (Lembaga Pengelola Dana Pendidikan)

Sponsor details

Ministry of Finance of Republic of Indonesia
dr. Wahidin Raya Street No1
Jakarta
10710
Indonesia
+6221-3500842
tesisdisertasi.lpdp@kemenkeu.go.id

Sponsor type

Government

Website

http://www.lpdp.kemenkeu.go.id/program/pengelolaan-dana/#

Funders

Funder type

Government

Funder name

Lembaga Pengelola Dana Pendidikan (LPDP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Thesis defence in Faculty of Medicine, Diponegoro University, March 2018

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. please contact Ms Haidi/Kiki, email address; hemasemarang@gmail.com, type of data=excel, the data will become available for 10 years, the access criteria data will be shared including with hematologist that interesting in myeloma research, the types of analyses dependent on their study purpose, and the mechanism; please send email to us with the study protocol and we will discuss to our ethical committee

Intention to publish date

03/03/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2019: Internal review. 08/11/2019: Trial’s existence confirmed by Komisi Etik Penelitian Kesehatan