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Alkylating agents
Chemotherapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Qaiser Bashir
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay
Patients with non-secretory multiple myeloma but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new chemotherapy drug to treat multiple myeloma before a stem cell transplant.
Who is the study for?
This trial is for newly-diagnosed multiple myeloma patients who can undergo donor stem cell transplantation. They must have a creatinine clearance of >= 40 mL/min, normal heart and liver function, no severe infections or HIV, not pregnant or breastfeeding, and agree to use contraception. Participants should be responsive to initial therapy and have a performance score indicating they can care for themselves.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Melphalan Hydrochloride as pre-transplant chemotherapy compared to standard treatments in preventing the return of multiple myeloma after receiving healthy stem cells from a donor. It aims to find the best dose with acceptable side effects.See study design
What are the potential side effects?
Melphalan Hydrochloride may cause damage to bone marrow cells including blood-forming cells leading to low blood counts, risk of infection, bleeding issues, potential harm to organs like lungs and liver based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma is stable or responding to treatment.
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My multiple myeloma doesn't show in blood tests but can be seen on scans.
Select...
My lung function tests are more than half the expected value for my age and size.
Select...
My kidneys work well enough to clear at least 40 mL/min of creatinine.
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I am able to care for myself but cannot do normal activities or work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity of melphalan hydrochloride
The Pharmacokinetics of melphalan hydrochloride parameters will assessed.
Secondary outcome measures
Complete response rate (CR)
Incidence of treatment related mortality (TRM)
Progression-free survival (PFS)
+1 moreSide effects data
From 2022 Phase 3 trial • 665 Patients • NCT0056756784%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
57600-Nausea
3%
65900-Pleural effusion
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
66300-Pneumonitis
1%
42600-Hypoalbuminemia
1%
71500-Respiratory failure
1%
26600-Duodenal obstruction
1%
69700-Rash maculo-papular
1%
23000-Confusion
1%
34000-Fibrinogen decreased
1%
45800-INR increased
1%
73900-Serum amylase increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 (melphalan hydrochloride, HSCT, filgrastim)Experimental Treatment3 Interventions
PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L.
Group II: Group 1 (melphalan hydrochloride, HSCT, filgrastim)Experimental Treatment3 Interventions
PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
FDA approved
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Filgrastim
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,719 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,755 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,091 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,668 Patients Enrolled for Multiple Myeloma
Qaiser BashirPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
97 Total Patients Enrolled
1 Trials studying Multiple Myeloma
94 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My multiple myeloma is stable or responding to treatment.Your bilirubin levels should be below a certain number, unless you have a condition called Gilbert syndrome.My multiple myeloma doesn't show in blood tests but can be seen on scans.Your heart's pumping function at rest is above 40% within the last 3 months.My lung function tests are more than half the expected value for my age and size.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I am not pregnant or breastfeeding.My kidneys work well enough to clear at least 40 mL/min of creatinine.I agree to use birth control as advised by the study doctor during treatment.I have had an organ transplant and am on immunosuppressive drugs.I've had at least two rounds of treatment and it's been 2-12 months since my first dose.You have tested positive for HIV.I have had a bone marrow transplant as part of a tandem transplantation.Your ALT and AST levels are not more than 2.5 times the upper limit of normal.I do not have any uncontrolled infections.I am able to care for myself but cannot do normal activities or work.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (melphalan hydrochloride, HSCT, filgrastim)
- Group 2: Group 2 (melphalan hydrochloride, HSCT, filgrastim)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Am I eligible to join this experiment?
"This study is enrolling 60 individuals aged 18 - 70 with a current diagnosis of multiple myeloma. Furthermore, applicants must have achieved a Karnofsky performance score of at least 70%, agree to use birth control methods specified by the doctor during treatment, and be 2-12 months out from completing their initial systemic therapy (mobilization therapies not included)."
Answered by AI
Is this investigation open to geriatric individuals?
"This clinical trial is limited to individuals between 18 and 70. There are 153 trials that cater specifically to those younger than 18, while 978 studies focus on seniors aged 65 or older."
Answered by AI
Are there still opportunities to join this medical research endeavor?
"According to clinicaltrials.gov, this medical trial is currently searching for participants; it was first published on October 9th 2019 and the details were most recently edited November 4th 2022."
Answered by AI
What is the current enrollment capacity for this clinical trial?
"Affirmative. According to the details provided on clinicaltrials.gov, this medical trial was posted in October of 2019 and has been actively recruiting since then - with its most recent update being dated November 4th 2022. The study requires 60 participants from one single site."
Answered by AI
What diseases or conditions can Autologous Hematopoietic Stem Cell Transplantation be employed to alleviate?
"Autologous Hematopoietic Stem Cell Transplantation has been found to be efficacious in treating severe congenital neutropenia, leukemia, myelocytic-acute forms and amyloidosis."
Answered by AI
What is the ultimate goal of this trial?
"The primary purpose of this trial will be to assess the pharmacokinetics of melphalan hydrochloride within 30 days after infusion. Secondary outcomes include progression-free survival computed from date of injection and rate of minimal residual disease as well as complete response rate, both determined by posterior probability and credible intervals through beta priors."
Answered by AI
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