AzTrials
AzTrials

Multiple MyelomaNCT06515249

Integrative Therapies in Multiple Myeloma

A study testing Integrative medicine in people with Multiple Myeloma, run by Bnai Zion Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Multiple myeloma is a hematologic malignancy that can cause anemia, renal failure, bone disease, and hypercalcemia. Today, myeloma is considered a chronic disease and most patients will receive ongoing biological treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Integrative medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteIsrael
Study dates
15 Jul 2024to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18
  • Diagnosis of multiple myeloma
  • Possibility to answer questionnaires once a month in Hebrew, Arabic or Russian
  • Signing an informed consent form

Who cannot join

  • Age under 18 years
  • In patients who will receive acupuncture: platelet level below 20x10^9/L
  • In patients who will receive reflexology: deep vein thrombosis in the leg
  • Hemodynamic instability
  • Psychiatric disorder impairing competence

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ilana Levy Yurkovski, MD contact

+972525086128

ilana.levy@b-zion.org.il

Israel1 site, 1 recruiting
  • Bnai Zion Medical Center

    Haifa, 3339419

    Miriam Goldberg, 972-48359351, miriam.goldberg@b-zion.org.il

    Ilana Levy Yurkovski, MD

    Recruiting

Other trials in Israel

About this study

Official title: Effectiveness and Safety of Integrative Therapies in Multiple Myeloma

Multiple myeloma is a hematologic malignancy that can cause anemia, renal failure, bone disease, and hypercalcemia. Today, myeloma is considered a chronic disease and most patients will receive ongoing biological treatments. As a result, this disease causes a number of symptoms related to the disease itself or its treatment, which include, among others, weakness and fatigue, bone or nerve pain, depression and anxiety, gastrointestinal symptoms, impairment of sexual function, etc. These symptoms cause significant damage to quality-of-life which is similar in patients who receive different treatment lines. As a result, the FDA emphasized quality-of-life as a key outcome for the approval of new drugs for the disease.

The conventional therapeutic approach to the various symptoms is based on supportive care guidelines including pharmacological and non-pharmacological treatment of pain, gastrointestinal symptoms, psychological components, etc. These treatments involve side effects and usually refer to individual symptoms.

Read more

Complementary and integrative medicine includes treatments of touch, movement, mind-body, acupuncture, nutrition and nutritional supplements. Many studies have shown the effectiveness of these treatments on various symptoms in cancer patients including pain, depression and anxiety, fatigue and weakness, gastrointestinal symptoms, etc. In myeloma patients, the effect of diet and nutritional supplements was mainly examined, but there is also little information on the effectiveness of mind-body treatments on symptoms of anxiety and depression, as well as acupuncture on neuropathy or on symptoms experienced by myeloma patients around autologous bone marrow transplantation.

In recent years, a wide variety of new drugs have entered the market that cause side effects that were unknown until now and little is known about the effect of complementary medicine treatments on symptoms and quality-of-life of myeloma patients since the development of these drugs.

In this study we will examine the effect of complementary and integrative medicine treatments (including acupuncture, touch, movement, mind-body) on the quality-of-life and symptoms that characterize myeloma patients during treatment with different lines of therapy, including new drugs.

Patients with a diagnosis of multiple myeloma who meet the study\'s inclusion criteria will be divided into the intervention group (complementary medicine treatments) and the control group (no treatments) according to their preferences. All the patients of the intervention group and the patients of the control group who agree will be asked to fill out quality-of-life questionnaires validated and translated into Hebrew, Arabic and Russian before the start of the treatment. The questionnaires include European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) which is a general quality-of-life questionnaire for cancer patients, with the addition of MY20 which is an addition of 20 specific questions for patients with multiple myeloma, the Edmonton Symptom Assessment System (ESAS) questionnaire which examines the severity of 10 common symptoms in patients with malignant disease, and the EuroQol-5 Dimension (EQ-5D) questionnaire which examines quality-of-life in cancer patients and is used as a primary outcome in many clinical studies. The same questionnaires will be sent again 1-2 weeks after the end of the treatments in the intervention group and 6-8 weeks after recruitment in the control group. Socio-demographic and medical data will also be collected from the patients and their medical records.

Being tested
Integrative medicine
Keywords
Multiple Myeloma, Integrative Medicine, Quality-of-life, Complementary medicine, Hematology, Acupuncture, Mind-body, Touch
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrative medicineOther

    Integrative medicine treatments including acupuncture, touch, movement, mind-body, as patient\'s and staff\'s choice

Study groups in NCT06515249
Study groupRoleWhat they receive
Integrative medicineExperimentalIntegrative medicine treatments including acupuncture, touch, movement, mind-body, as patient's and staff's choice
Receives: Other: Integrative medicine
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality-of-life specific to myeloma patients

    EORTC QLQ-MY2 (European Organization for the Research and Treatment of Cancer Quality of Life for Myeloma patients) score at 1-2 weeks after end-of-treatment in intervention group and 7-8 weeks after recruitment in control group. It comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. Domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

    Measured: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

Secondary outcomes (7)
  1. General quality-of-life evaluation

    European Organization Research for Treatment of cancer core quality of life (EORTC-QLQ-C30) questionnaire summary score which is calculated from the mean of 13 of the 15 quality-of-life (QLQ-C30) scales of the questionnaire = (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ 100-Fatigue+ 100-Pain+ 100-Nausea_Vomiting+ 100-Dyspnoea+ 100-Sleeping Disturbances+ 100-Appetite Loss+ 100-Constipation+ 100-Diarrhoea)/13. Scores range from minimum 0 to maximum 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

    Measured: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

  2. Symptom relief

    Edmonton Symptom Assessment System (ESAS): assesses the severity over time of nine symptoms common among patients with cancer and other advanced illness: pain, tiredness, drowsiness, nausea, shortness of breath, appetite, depression, anxiety, and wellbeing. A higher score represents a higher ("worse") level of symptoms.

    Measured: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group

  3. Compliance to conventional therapy

    Relative dose intensity (RDI) which is the ratio of delivered dose intensity (DDI) of myeloma treatment with standard dose intensity (SDI) of myeloma treatment = DDI/SDI

    Measured: From enrollment to 1 year after enrollment

  4. Economic analysis

    Calculation of quality-adjusted life years based on EuroQol-5 Dimension (EQ-5D) scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

    Measured: From enrollment to 3 months after enrollment

  5. Overall response rate (ORR) to myeloma treatment

    Percentage of patients who have a partial response or complete response to the treatment of myeloma

    Measured: From enrollment to 1 year after enrollment

  6. Progression-free survival (PFS)

    The length of time during and after the treatment of myeloma that patient lives and disease does not progress

    Measured: From enrollment to 2 years after enrollment

  7. Overall survival (OS)

    The length of time during and after the treatment of myeloma that patient lives

    Measured: From enrollment to 2 years after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2024
  2. Study start15 Jul 2024
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06515249
Sponsor's protocol ID
0054-24-BNZ
Status last verified
Sep 2026
First submitted
15 Jul 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Integrative medicine in people with Multiple Myeloma, run by Bnai Zion Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ilana Levy Yurkovski, MD (+972525086128, ilana.levy@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality-of-life specific to myeloma patients (time frame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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