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Proton Beam Therapy

Group 4 - Dose Schedule 4 for Multiple Myeloma

Q: Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

<p>As per the data on clinicaltrials.gov, recruitment is presently closed for this investigation. The study was introduced on May 1st, 2024, with the latest revision made on February 13th, 2024. While enrollment isn't active for this specific trial currently, there exist a pool of 812 other ongoing trials actively seeking participants.</p>

Q: What are the risks associated with Group 1 - Dose Schedule 1 for individuals undergoing treatment?

<p>Based on our evaluation at Power, Group 1 - Dose Schedule 1 is rated as a 1 on the safety scale from 1 to 3. This rating reflects the early Phase 1 nature of the trial and the limited available data supporting both safety and efficacy.</p>

Phase 1

Waitlist Available

Led By Yasmin Hasan, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be males and females ≥ 18 years of age at the time of informed consent

Participants who are women must not be breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is for people with multiple myeloma who are recommended to have radiation therapy. The doctors want to test if a shorter course of radiation treatment, with slightly higher daily doses, is safe and

Who is the study for?

This trial is for people with multiple myeloma who need radiation therapy. It's testing if a shorter course of higher-dose radiation (hypofractionation) over fewer days can be as safe and effective as the standard 2-3 week treatment.Check my eligibility

What is being tested?

The study is examining hypofractionated radiation therapy, which means giving larger doses of radiation in each session but reducing the total number of sessions. The goal is to see if this approach maintains safety and effectiveness.See study design

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, mild swelling or pain at the treatment site. Higher doses per session could possibly increase these effects compared to traditional schedules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am not currently breastfeeding.

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I am mostly bedridden due to my health condition.

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My multiple myeloma has returned or is not responding to treatment, and I have up to 5 bone lesions treatable with radiation.

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I have a tumor that can be measured and is suitable for radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose of Radiation of Per Fraction

Secondary outcome measures

Local Control of the treated Lesion

Overall Response Rate

Progression-free Survival

+2 more

Side effects data

From 2008 Phase 3 trial • 243 Patients • NCT00216125

60%

NEUTROPHILS/GRANULOCYTES (ANC/AGC)

54%

LEUKOCYTES (TOTAL WBC)

51%

FATIGUE (ASTHENIA, LETHARGY, MALAISE)

48%

DYSPNEA (SHORTNESS OF BREATH)

43%

ESOPHAGITIS

38%

NAUSEA

36%

HEMOGLOBIN

35%

HAIR LOSS/ALOPECIA (SCALP OR BODY)

35%

COUGH

33%

PAIN

32%

ANOREXIA

31%

PAIN - OTHER (SPECIFY, __)

29%

PLATELETS

26%

VOMITING

26%

CONSTIPATION

24%

DIARRHEA

19%

MOOD ALTERATION

18%

NEUROPATHY: SENSORY

18%

INFECTION - OTHER (SPECIFY, __)

18%

WEIGHT LOSS

17%

DIZZINESS

15%

FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)

15%

PNEUMONITIS/PULMONARY INFILTRATES

15%

HEARTBURN/DYSPEPSIA

13%

INSOMNIA

13%

INFECTION - OTHER

12%

FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)

12%

GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)

11%

DEHYDRATION

11%

GASTROINTESTINAL - OTHER (SPECIFY, __)

11%

HYPOTENSION

10%

LYMPHOPENIA

10%

HEMORRHAGE, PULMONARY/UPPER RESPIRATORY

10%

RASH/DESQUAMATION

10%

RASH: DERMATITIS ASSOCIATED WITH RADIATION

MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)

CARDIAC GENERAL - OTHER (SPECIFY, __)

ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)

ALKALINE PHOSPHATASE

PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)

MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)

SWEATING (DIAPHORESIS)

SODIUM, SERUM-LOW (HYPONATREMIA)

VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)

POTASSIUM, SERUM-LOW (HYPOKALEMIA)

SUPRAVENTRICULAR AND NODAL ARRHYTHMIA

CALCIUM, SERUM-LOW (HYPOCALCEMIA)

AUDITORY/EAR - OTHER (SPECIFY, __)

SYNCOPE (FAINTING)

METABOLIC/LABORATORY - OTHER (SPECIFY, __)

CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)

HICCOUGHS (HICCUPS, SINGULTUS)

CREATININE

PLEURAL EFFUSION (NON-MALIGNANT)

CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)

HYPERTENSION

MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)

BLOOD/BONE MARROW - OTHER (SPECIFY, __)

POTASSIUM, SERUM-HIGH (HYPERKALEMIA)

THROMBOSIS/THROMBUS/EMBOLISM

HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)

RIGORS/CHILLS

DERMATOLOGY/SKIN - OTHER (SPECIFY, __)

MUCOSITIS/STOMATITIS (CLINICAL EXAM)

NEUROPATHY: MOTOR

COAGULATION - OTHER (SPECIFY, __)

HYPOXIA

URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)

HEMORRHAGE/BLEEDING - OTHER

EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS

HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)

PERICARDIAL EFFUSION (NON-MALIGNANT)

BICARBONATE, SERUM-LOW

RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)

ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)

ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)

MEMORY IMPAIRMENT

OCULAR/VISUAL - OTHER (SPECIFY, __)

RENAL/GENITOURINARY - OTHER

URINARY FREQUENCY/URGENCY

HOT FLASHES/FLUSHES

CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)

GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)

COLITIS

CARDIAC ARRHYTHMIA - OTHER

CONSTITUTIONAL SYMPTOMS - OTHER

DYSPHAGIA (DIFFICULTY SWALLOWING)

AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)

BLOOD/BONE MARROW - OTHER

URIC ACID, SERUM-HIGH (HYPERURICEMIA)

INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)

VENTRICULAR ARRHYTHMIA

LYMPHATICS - OTHER (SPECIFY, __)

FISTULA, GI

PRURITUS/ITCHING

WATERY EYE (EPIPHORA, TEARING)

SODIUM, SERUM-HIGH (HYPERNATREMIA)

SEIZURE

ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)

CALCIUM, SERUM-HIGH (HYPERCALCEMIA)

HEMORRHAGE, GI

MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)

PHOTOSENSITIVITY

PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)

WEIGHT GAIN

PAIN - OTHER

HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM

PULMONARY/UPPER RESPIRATORY - OTHER

ALKALOSIS (METABOLIC OR RESPIRATORY)

CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)

SYNDROMES - OTHER (SPECIFY, __)

ARTHRITIS (NON-SEPTIC)

BILIRUBIN (HYPERBILIRUBINEMIA)

DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)

INFECTION WITH UNKNOWN ANC

INJECTION SITE REACTION/EXTRAVASATION CHANGES

GASTROINTESTINAL - OTHER

GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)

HYPOPIGMENTATION

NAIL CHANGES

100%

80%

60%

40%

20%

Study treatment Arm

Consolidation Docetaxel

Observation Only

Pre-Randomization

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4 - Dose Schedule 4Experimental Treatment1 Intervention

In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants will be assigned to one of the dose schedules and they will know this ahead of time. The study doctor will tell each participant which study group and dose schedule they been assigned. For most participants, the actual time on the radiation treatment machine will be in the range of 30 to 60 minutes. The mold will be removed after the treatment. The number of treatments to each tumor will depend on which treatment group the participant is enrolled on: The longest possible treatment group would be 10 treatments in duration of about 2 weeks of treatment and the shortest possible treatment group would be 1 treatment.

Group II: Group 3 - Dose Schedule 3Experimental Treatment1 Intervention

Group III: Group 2 - Dose Schedule 2Experimental Treatment1 Intervention

Group IV: Group 1 - Dose Schedule 1Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 3

~1020

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,747 Total Patients Enrolled

16 Trials studying Multiple Myeloma

1,939 Patients Enrolled for Multiple Myeloma

Yasmin Hasan, MDPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"As per the data on clinicaltrials.gov, recruitment is presently closed for this investigation. The study was introduced on May 1st, 2024, with the latest revision made on February 13th, 2024. While enrollment isn't active for this specific trial currently, there exist a pool of 812 other ongoing trials actively seeking participants."

Answered by AI

What are the risks associated with Group 1 - Dose Schedule 1 for individuals undergoing treatment?

"Based on our evaluation at Power, Group 1 - Dose Schedule 1 is rated as a 1 on the safety scale from 1 to 3. This rating reflects the early Phase 1 nature of the trial and the limited available data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionation (Radiation) Trial for Multiple Myeloma

2024. "Hypofractionation (Radiation) Trial for Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06270888.

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