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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 6 weeks post transplant and 4 years post transplant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 ~ 6 weeks post transplant and 4 years post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks post transplant and 4 years post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of escalating doses of bortezomib with or without TMI in combination with FLU and MEL as preparative regimen for allogeneic hematopoietic stem cell transplant in patients with high risk multiple myeloma
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 outcome measures
Frequency of clinical response (i.e., complete, partial, or very good partial response)
Frequency of primary and secondary engraftment failure
Incidence of acute and chronic graft-versus-host disease
+4 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%
Proteinuria
19%
Diarrhea
19%
Elevated SGOT(serum glutamic oxaloacetic transaminase)
17%
Chills
17%
Injection reaction
17%
Alkaline phosphate elevated
17%
Hematuria
17%
Thrombocytopenia
14%
Anemia
14%
Weight gain
12%
Neutropenia
12%
Cough
12%
Malaise
10%
Flu-like symptoms
10%
Dry skin
10%
Elevated D bili
10%
Hypotension
10%
Rash
7%
Decreased appetite
7%
Pruritis
7%
Elevated total bilirubin
7%
Intermittent pain in shaft of R tibia
7%
Myalgia
7%
Congestion
7%
flu symptoms
7%
Back pain
7%
Insomnia
7%
Hyperglycemia
7%
Intermittent H/A (headache)
7%
Low albumin
7%
Stomach ache
7%
Upset stomach
7%
Sore throat
7%
Stomach pain
7%
URI (upper respiratory infection)
7%
Weight loss
5%
Erythema
5%
Stye (L) lower corner eye
5%
Emesis
5%
Stuffy nose
5%
Lower back soreness
5%
Cold
5%
Dizziness
5%
AST (SGOT)
5%
Flush, facial
5%
Abdominal pain
5%
Dry lips
5%
Elevated magnesium
5%
Constipation
5%
Anxiety
5%
Hypothyroid
5%
Nausea/vomiting
5%
Elevated glucose
5%
Lips numb
5%
Flushing
5%
Loose stool
5%
Leg pain
5%
Joint pain
5%
Numbness in feet and hands
5%
Decreased L leg flexibility
5%
Edema, facial
5%
Discoloration skin (L) hand
5%
Heartburn
2%
Platelets
2%
Itching
2%
Fever blister
2%
Ptosis
2%
Lethargic
2%
Perior edema
2%
Dizzy
2%
Pain R foot
2%
Foot drop
2%
Gas pains
2%
Gas build-up
2%
Swell tongue
2%
L anterior chest pain
2%
Pain injection site
2%
Rash, arm/chs
2%
Sweating
2%
Flushed skin
2%
Cough nonproductive
2%
Itchy L. leg
2%
Nose congestion
2%
Patchy dry skin/itch trunk
2%
Swell ankle
2%
Leukocytes
2%
Pain
2%
Runny nose
2%
Stiff neck
2%
Fever (by touch)
2%
Left chest pressure
2%
Fever-low grade (by touch)
2%
Skin peeling
2%
Itching/injection site
2%
Petechiae
2%
Quad muscle soreness
2%
Abdominal discomfort
2%
Neutrophils
2%
Bilateral flank pain
2%
Eye pain
2%
Eyes watery
2%
Flatulence
2%
DVT (deep vein thrombosis)
2%
Acne (rash) on chest
2%
Anorexia
2%
Throat pain
2%
Vascular
2%
Decreased uric acid
2%
Drainage on foot
2%
Elevated BUN
2%
ALT (SGPT)
2%
Bitter taste in mouth
2%
Induration injection site
2%
Intermittent insomnia
2%
Elevated LFT's (liver function tests)
2%
Flush cheeks
2%
Skin rash
2%
Ear pain/infection
2%
Ulceration L heel
2%
Hemorrhage
2%
Elevated creatin
2%
CPK (Creatine phosphokinase)
2%
Chest tightness
2%
Decreased urine output (o/p)
2%
Acid reflux
2%
Eye swollen
2%
Impetigo
2%
INC SGPT (serum glutamic pyruvic transaminase)
2%
Intermittent cramping legs
2%
Rash with macules/papules
2%
Achiness
2%
Anxiety symptoms
2%
Decreased flexibility swelling left leg
2%
Glucosuria
2%
Hemoglobin
2%
Abdominal pain or cramping
2%
Cough (mild, intermittent)
2%
Gum line bump (L. upper)
2%
Hypoglycemia
2%
Indigestion
2%
Bad taste in mouth
2%
Cough (dry)
2%
Cranky
2%
Dry cough
2%
Elevated creatinine
2%
Low potassium
2%
Achy
2%
Generalized pain
2%
Hyponatremia
2%
Bruise
2%
Chelitis
2%
Double vision
2%
Dry heaves
2%
Dry scaly peeling skin
2%
Dry scaly skin
2%
Flushed
2%
Injection sclera
2%
Elevated creat
2%
Fever (by touch-low grade)
2%
INC SGOT (serum glutamic oxaloacetic transaminase)
2%
Glands swoll
2%
Increase fatigue
2%
Loose stools
2%
Rash/redness (top of arm)
2%
Rhinorrhea
2%
Muscle aches
2%
Myalgia-bilateral thighs
2%
Occipital (mild pain)
2%
Otitis media
2%
Pain, legs
2%
Hemorrhage sclera
2%
Kidney stone
2%
Left ear ringing
2%
Nose bleed
2%
Restlessness
2%
Hot feeling
2%
Hyperbilirubin
2%
Hyperthyroid
2%
Induration
2%
Hypertension
2%
Inf IV site
2%
Intermittent fatigue
2%
Jaw pain
2%
Malleolus (pain)
2%
Muscle atrophy
2%
Rash, chest
2%
Swelling lip
2%
Elev phos
2%
Hypomagnesemia
2%
Itching (chest)
2%
Swelling-lower extremity
2%
Tachycardia
2%
Tiredness
2%
Weakness (L. leg)
2%
Irritable
2%
Itchy legs
2%
Loss of balance
2%
Low CO2
2%
Minor sore throat
2%
Prickling sensation
2%
Quad/muscle pain
2%
Rhinitis
2%
Shoulder pain
2%
Nasal drainage
2%
Night sweat
2%
Pretib edema
2%
Puffy face
2%
Scrape on face
2%
Soreness under ribs
2%
Pressure in chest with inhalation
2%
Stomach burning
2%
Elevated uric acid
2%
Soreness/achiness
2%
Ulceration (R) heel
2%
Weakness
2%
Pain R hip
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
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
fludarabine phosphate
2000
Completed Phase 3
~2660
total marrow irradiation
2004
Completed Phase 2
~80
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330
sirolimus
2006
Completed Phase 4
~1510
bortezomib
2011
Completed Phase 3
~850
tacrolimus
2004
Completed Phase 4
~3750
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,442 Total Patients Enrolled
83 Trials studying Leukemia
4,984 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
1,513 Trials studying Leukemia
384,682 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to join this clinical trial?
"To be considered for this trial, candidates must have one of the three forms of leukemia and fit within the age range between 18-70 years old. Currently, 27 participants are being recruited in total."
Answered by AI
Does this research endeavor encompass members of the geriatric population?
"This clinical trial is recruiting adults who are between 18 and 70 years old."
Answered by AI
How many participants are involved in this clinical investigation?
"This investigation has already ceased its search for participants. It was first posted on January 28th 2011, and the last update to this trial occured on March 17th 2022. If you are looking for current studies, 809 trials related to leukemia and plasma cell research are in need of volunteers as well as 693 peripheral blood stem cell transplantation studies that require candidates."
Answered by AI
What medical conditions are generally addressed with peripheral blood stem cell transplantation?
"Peripheral Blood Stem Cell Transplantation is frequently used to treat atopic dermatitis, but it can also be deployed against numerous other afflictions such as kidney transplant rejection and psoriasis. Oral lichen planus has been shown to respond well to this type of intervention too."
Answered by AI
Could you please elucidate the precedent of peripheral blood stem cell transplantation trials?
"Currently, 693 clinical trials pertaining to peripheral blood stem cell transplantation are in operation. 84 of these studies have advanced beyond Phase 2 testing and into Phase 3. While the vast majority of these medical trials are being conducted within Philadelphia, Pennsylvania, 12900 sites around the globe offer this life-saving treatment."
Answered by AI
What risks are associated with peripheral blood stem cell transplantation for patients?
"Due to the limited evidence available, peripheral blood stem cell transplantation was given a score of 1 on our safety scale. This is indicative that it only in its earliest stages of clinical testing and has yet to be fully evaluated for efficacy or safety."
Answered by AI
Is enrollment in this clinical trial still available?
"This trial is no longer enrolling patients; the experiment was first posted on January 28th 2011 and most recently updated on March 17th 2022. For those interested in taking part in other trials, there are currently 809 clinical studies for leukemia patients and 693 research projects for individuals undergoing peripheral blood stem cell transplants actively recruiting participants."
Answered by AI
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