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.
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.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 3339419
Miriam Goldberg, 972-48359351, miriam.goldberg@b-zion.org.il
Ilana Levy Yurkovski, MD
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.
- Conditions
- Multiple Myeloma
- 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 group | Role | What they receive |
|---|---|---|
| Integrative medicine | Experimental | Integrative medicine treatments including acupuncture, touch, movement, mind-body, as patient's and staff's choice Receives: Other: Integrative medicine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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.
- First posted23 Jul 2024
- Study start15 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilana Levy Yurkovski, MD, Principal investigator, Bnai Zion Medical Center, Haifa, Israel
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Integrative Therapies in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06515249
- Acronym / sponsor ID
- 0054-24-BNZ
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Integrative Medicine, Quality-of-life, Complementary medicine, Hematology, Acupuncture, Mind-body, Touch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative medicine | Experimental | Other: Integrative medicineIntegrative medicine treatments including acupuncture, touch, movement, mind-body, as patient's and staff's choice |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- Diagnosis of multiple myeloma
- Possibility to answer questionnaires once a month in Hebrew, Arabic or Russian
- Signing an informed consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative medicineIntegrative medicine treatments including acupuncture, touch, movement, mind-body, as patient\'s and staff\'s choice | Other | Integrative medicine |
Primary outcome
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
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.
7 secondary outcomes
General quality-of-life evaluation
Time frame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
Symptom relief
Time frame: From enrollment to 2 weeks after end of treatment in intervention group and 8 weeks after enrollment in control group
Compliance to conventional therapy
Time frame: From enrollment to 1 year after enrollment
Economic analysis
Time frame: From enrollment to 3 months after enrollment
Overall response rate (ORR) to myeloma treatment
Time frame: From enrollment to 1 year after enrollment
Progression-free survival (PFS)
Time frame: From enrollment to 2 years after enrollment
Overall survival (OS)
Time frame: From enrollment to 2 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilana Levy Yurkovski, MD principal investigator
Bnai Zion Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
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.