Trial Outcomes & Findings for Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma (NCT NCT04459416)

Last Updated: 2025-10-20

Results Overview

at a given time divided by the total number of patients randomized to that group at Day 7) by review of medication records and urine drug test

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

299 participants

Primary outcome timeframe

at day 7

Results posted on

2025-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Acupuncture Plus Usual Care Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
Overall Study STARTED	151	147
Overall Study COMPLETED	141	134
Overall Study NOT COMPLETED	10	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Acupuncture Plus Usual Care Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	8	10
Overall Study Disease progression	0	3

Baseline Characteristics

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture Plus Usual Care n=151 Participants Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=147 Participants Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Total n=298 Participants Total of all reporting groups
Age, Continuous	58.4 years n=5 Participants	58.1 years n=7 Participants	58.3 years n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	68 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	79 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	141 Participants n=5 Participants	135 Participants n=7 Participants	276 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	114 Participants n=5 Participants	121 Participants n=7 Participants	235 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	151 Participants n=5 Participants	147 Participants n=7 Participants	298 Participants n=5 Participants

PRIMARY outcome

Timeframe: at day 7

at a given time divided by the total number of patients randomized to that group at Day 7) by review of medication records and urine drug test

Outcome measures

Outcome measures
Measure	Acupuncture Plus Usual Care n=141 Participants Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=134 Participants Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
the Number of Patients Using Opioids at a Given Time Using Opioid	35 Participants	43 Participants
the Number of Patients Using Opioids at a Given Time No Opioid Use	106 Participants	91 Participants

PRIMARY outcome

Timeframe: at day 90

at a given time divided by the total number of patients randomized to that group at Day 90) by review of medication records and urine drug test

Outcome measures

Outcome measures
Measure	Acupuncture Plus Usual Care n=141 Participants Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=134 Participants Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
the Number of Patients Using Opioids at a Given Time Using Opioid	6 Participants	8 Participants
the Number of Patients Using Opioids at a Given Time No Opioid Use	135 Participants	126 Participants

PRIMARY outcome

Timeframe: At baseline

measured by M. D. Anderson Symptom Inventory Blood and Marrow Transplantaion (MDASI-BMT). The symptoms rated are feeling physically sick, weak, diarrhea, mouth sores, and bleeding. All symptoms are rated with reference to "the last 24 hours" on 0-10 numeric scales from "not present" to "as bad as you can imagine." MDASIBMT Total Symptom Severity score will serve as the symptom burden primary endpoint. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical scale with 0 being "not present" and 10 being "as bad as you can imagine. Total symptom severity was calculated by averaging all 18 items in the scale

Outcome measures

Outcome measures
Measure	Acupuncture Plus Usual Care n=141 Participants Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=134 Participants Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
Symptom Burden	2.06 MDASIBMT Total Symptom Severity score Interval 1.86 to 2.25	2.06 MDASIBMT Total Symptom Severity score Interval 1.86 to 2.26

PRIMARY outcome

Timeframe: At Day 7

Outcome measures

Outcome measures
Measure	Acupuncture Plus Usual Care n=141 Participants Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=134 Participants Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
Symptom Burden	2.96 MDASIBMT Total Symptom Severity score Interval 2.66 to 3.26	2.95 MDASIBMT Total Symptom Severity score Interval 2.63 to 3.27

PRIMARY outcome

Timeframe: At Day 90

Outcome measures

Outcome measures
Measure	Acupuncture Plus Usual Care n=141 Participants Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=134 Participants Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
Symptom Burden	1.46 MDASIBMT Total Symptom Severity score Interval 1.2 to 1.72	1.40 MDASIBMT Total Symptom Severity score Interval 1.12 to 1.68

Adverse Events

Acupuncture Plus Usual Care

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acupuncture Plus Usual Care n=151 participants at risk Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.	Usual Care n=147 participants at risk Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
Injury, poisoning and procedural complications Bruising	17.2% 26/151 • 90 days	0.00% 0/147 • 90 days
General disorders Burning sensation	0.66% 1/151 • 90 days	0.00% 0/147 • 90 days
Skin and subcutaneous tissue disorders Skin discoloration	0.66% 1/151 • 90 days	0.00% 0/147 • 90 days
Musculoskeletal and connective tissue disorders Foot cramping	0.66% 1/151 • 90 days	0.00% 0/147 • 90 days
Respiratory, thoracic and mediastinal disorders Nose bleed	0.66% 1/151 • 90 days	0.00% 0/147 • 90 days
General disorders Pain/Soreness	4.6% 7/151 • 90 days	0.00% 0/147 • 90 days
General disorders Throbbing sensation	0.66% 1/151 • 90 days	0.00% 0/147 • 90 days
General disorders Tiredness	0.66% 1/151 • 90 days	0.00% 0/147 • 90 days

Additional Information

Dr. Gary Deng, MD, PhD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-8556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place