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Proteasome Inhibitor
Chemotherapy + Stem Cell Transplant for Multiple Myeloma
Phase 1
Waitlist Available
Led By Firoozeh Sahebi, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years post transplant
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the side effects and best dose of bortezomib when given together with fludarabine phosphate and melphalan with or without total marrow irradiation for patients with high-risk stage I or II multiple myeloma.
Who is the study for?
This trial is for high-risk stage I or II multiple myeloma patients who have relapsed on new therapies, had a previous stem cell transplant, or have specific genetic changes. They must be able to lie down for about an hour and meet certain health criteria like good heart function and kidney function. People with severe peripheral neuropathy, major medical issues, HIV, active hepatitis B or C, liver cirrhosis, or untreated infections cannot join.
What is being tested?
The trial tests the side effects and best dose of bortezomib combined with fludarabine phosphate and melphalan chemotherapy drugs. Some patients will also receive total marrow irradiation before donor stem cell transplant to see if it helps stop cancer growth and prevents immune rejection.
What are the potential side effects?
Possible side effects include reactions from the enzyme-blocking drug bortezomib that may affect cell growth; chemotherapy-related nausea, fatigue, risk of infection; organ inflammation due to radiation; plus risks associated with stem cell transplantation such as graft-versus-host disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years post transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose of bortezomib as defined as the highest dose tested in which none or only one patient experiences dose limiting toxicity attributable to the study regimen
Secondary study objectives
Frequency of clinical response (i.e., complete, partial, or very good partial response)
Minimal residue disease
Overall survival
+1 moreSide effects data
From 2008 Phase 2 trial • 42 Patients • NCT0000156638%
Fatigue
31%
Eosinophilia
29%
Fever
29%
Nausea
26%
Nasal congestion
26%
Headache
24%
Elevated SGPT (serum glutamic pyruvic transaminase)
24%
Vomiting
19%
Diarrhea
19%
Elevated SGOT(serum glutamic oxaloacetic transaminase)
19%
Proteinuria
17%
Chills
17%
Alkaline phosphate elevated
17%
Hematuria
17%
Injection reaction
17%
Thrombocytopenia
14%
Anemia
14%
Weight gain
12%
Cough
12%
Malaise
12%
Neutropenia
10%
Dry skin
10%
Elevated D bili
10%
Flu-like symptoms
10%
Hypotension
10%
Rash
7%
Decreased appetite
7%
Back pain
7%
Congestion
7%
flu symptoms
7%
Insomnia
7%
Hyperglycemia
7%
Low albumin
7%
Intermittent pain in shaft of R tibia
7%
Intermittent H/A (headache)
7%
Myalgia
7%
Pruritis
7%
Sore throat
7%
Stomach ache
7%
Stomach pain
7%
Upset stomach
7%
URI (upper respiratory infection)
7%
Weight loss
7%
Elevated total bilirubin
5%
Anxiety
5%
Abdominal pain
5%
Constipation
5%
Cold
5%
AST (SGOT)
5%
Emesis
5%
Dizziness
5%
Dry lips
5%
Elevated glucose
5%
Elevated magnesium
5%
Erythema
5%
Flush, facial
5%
Flushing
5%
Lower back soreness
5%
Joint pain
5%
Loose stool
5%
Hypothyroid
5%
Leg pain
5%
Lips numb
5%
Nausea/vomiting
5%
Numbness in feet and hands
5%
Stuffy nose
5%
Stye (L) lower corner eye
5%
Decreased L leg flexibility
5%
Edema, facial
5%
Discoloration skin (L) hand
5%
Heartburn
2%
Ptosis
2%
Elevated creat
2%
Abdominal discomfort
2%
Abdominal pain or cramping
2%
Achiness
2%
Acne (rash) on chest
2%
Chelitis
2%
Anorexia
2%
CPK (Creatine phosphokinase)
2%
Neutrophils
2%
Bad taste in mouth
2%
Bruise
2%
Chest tightness
2%
Dizzy
2%
DVT (deep vein thrombosis)
2%
Skin rash
2%
Hemorrhage
2%
Leukocytes
2%
Bilateral flank pain
2%
Bitter taste in mouth
2%
Rash with macules/papules
2%
Anxiety symptoms
2%
Cranky
2%
Acid reflux
2%
Dry cough
2%
Achy
2%
ALT (SGPT)
2%
Decreased flexibility swelling left leg
2%
Cough nonproductive
2%
Decreased uric acid
2%
Cough (dry)
2%
Cough (mild, intermittent)
2%
Double vision
2%
Drainage on foot
2%
Dry scaly peeling skin
2%
Dry scaly skin
2%
Decreased urine output (o/p)
2%
Dry heaves
2%
Ear pain/infection
2%
Foot drop
2%
Elevated creatin
2%
Elevated BUN
2%
Flatulence
2%
Elevated LFT's (liver function tests)
2%
Elevated creatinine
2%
Eye pain
2%
Eye swollen
2%
Fever (by touch-low grade)
2%
Fever-low grade (by touch)
2%
Eyes watery
2%
Fever blister
2%
Fever (by touch)
2%
Flush cheeks
2%
Flushed skin
2%
Gas build-up
2%
Gum line bump (L. upper)
2%
Hemoglobin
2%
Hypertension
2%
Hyperthyroid
2%
Flushed
2%
Gas pains
2%
Generalized pain
2%
Hot feeling
2%
Glucosuria
2%
Glands swoll
2%
Hemorrhage sclera
2%
Induration injection site
2%
Irritable
2%
Loose stools
2%
Loss of balance
2%
Low CO2
2%
Hyperbilirubin
2%
Itching
2%
Itching/injection site
2%
L anterior chest pain
2%
Left ear ringing
2%
Lethargic
2%
Hypoglycemia
2%
INC SGOT (serum glutamic oxaloacetic transaminase)
2%
Indigestion
2%
Inf IV site
2%
Injection sclera
2%
Hypomagnesemia
2%
Hyponatremia
2%
Impetigo
2%
INC SGPT (serum glutamic pyruvic transaminase)
2%
Increase fatigue
2%
Induration
2%
Intermittent insomnia
2%
Itching (chest)
2%
Itchy L. leg
2%
Jaw pain
2%
Kidney stone
2%
Intermittent cramping legs
2%
Intermittent fatigue
2%
Left chest pressure
2%
Low potassium
2%
Malleolus (pain)
2%
Minor sore throat
2%
Muscle aches
2%
Muscle atrophy
2%
Myalgia-bilateral thighs
2%
Nasal drainage
2%
Nose bleed
2%
Pain
2%
Pain injection site
2%
Pain R foot
2%
Platelets
2%
Pressure in chest with inhalation
2%
Pretib edema
2%
Night sweat
2%
Nose congestion
2%
Occipital (mild pain)
2%
Otitis media
2%
Pain R hip
2%
Patchy dry skin/itch trunk
2%
Perior edema
2%
Petechiae
2%
Quad muscle soreness
2%
Rash, chest
2%
Prickling sensation
2%
Puffy face
2%
Quad/muscle pain
2%
Restlessness
2%
Rhinitis
2%
Rash, arm/chs
2%
Rash/redness (top of arm)
2%
Skin peeling
2%
Soreness under ribs
2%
Soreness/achiness
2%
Sweating
2%
Swell ankle
2%
Swell tongue
2%
Swelling lip
2%
Swelling-lower extremity
2%
Tachycardia
2%
Rhinorrhea
2%
Runny nose
2%
Scrape on face
2%
Shoulder pain
2%
Stiff neck
2%
Stomach burning
2%
Tiredness
2%
Vascular
2%
Weakness
2%
Throat pain
2%
Ulceration (R) heel
2%
Ulceration L heel
2%
Weakness (L. leg)
2%
Elevated uric acid
2%
Itchy legs
2%
Elev phos
2%
Pain, legs
2%
Skin sensation
2%
Scratch under left eye
2%
Itchy scratch under left eye
2%
Ears ringing
2%
Ears ringing and clogged
2%
Edema
2%
Edema media R mid-thigh
2%
Edema on foot
2%
Hives
2%
Pain tailbone
2%
Sore mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (bortezomib, fludarabine phosphate, melphalanExperimental Treatment7 Interventions
Patients receive fludarabine phosphate IV and melphalan IV as in Stratum I. Patients also receive bortezomib IV on days -6, -3, 1, and 4.
Group II: Group I (bortezomib, fludarabine phosphate, TMI, melphalan)Experimental Treatment8 Interventions
Patients receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients also undergo TMI BID on days -9 to -7. If no DLT is observed in the first cohort, bortezomib IV will be added on days -6 and -3 for subsequent cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sirolimus
2006
Completed Phase 4
~1510
bortezomib
2011
Completed Phase 3
~850
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330
fludarabine phosphate
2000
Completed Phase 3
~2660
tacrolimus
2004
Completed Phase 4
~3750
total marrow irradiation
2004
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,562 Total Patients Enrolled
90 Trials studying Leukemia
5,215 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,016,916 Total Patients Enrolled
1,535 Trials studying Leukemia
385,571 Patients Enrolled for Leukemia
Firoozeh Sahebi, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your disease has come back or not responded to new targeted treatments like thalidomide, lenalidomide, bortezomib, carfilzomib, or pomalidomide.You have severe peripheral neuropathy.You have multiple myeloma that has come back after a previous treatment with your own stem cells.You have been diagnosed with plasma cell leukemia.Your lung capacity for carbon monoxide (DLCO) needs to be at least 50%.You have a specific genetic abnormality in your bone marrow that puts you at high risk for the study.You can lie on your back for about 60 minutes, which is how long each treatment session will last.You should have a good physical condition with a score of 0 to II on the ECOG scale or at least 70% on the KPS scale.Your heart is pumping blood effectively, as shown by certain tests.Your lung function, measured by FEV1, is at least 50% of what it should be.Your kidneys work well enough to filter at least 60 milliliters of waste from your blood every minute.Your bilirubin level in the blood should be no higher than 2.0 mg/dl.You have HIV, active hepatitis B or C infection, or liver cirrhosis.You have a current viral, bacterial, or fungal infection that is not being treated, unless your doctor says it's under control. If you had a fungal infection before, you need to have finished the treatment and the infection should be gone.You have signs of lung disease on an x-ray, such as nodules or fluid around the lungs, unless a lung biopsy shows no signs of infection.You have poor kidney function or a clearance rate of less than 60 ml per minute.You must have a confirmed diagnosis of multiple myeloma through a tissue sample examination.You have a type of cancer that is getting worse despite trying new targeted treatments.Your SGOT and SGPT levels are not more than 2.5 times the normal limit.You have not received radiation treatment, or if you have, it was for a specific amount in certain areas of the body.You have had radiation treatment to certain areas of your body and are not eligible for the trial.A suitable donor is a sibling or unrelated person who matches your tissue type.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (bortezomib, fludarabine phosphate, melphalan
- Group 2: Group I (bortezomib, fludarabine phosphate, TMI, melphalan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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