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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 below
Select...
My multiple myeloma is stable or responding to treatment.
Select...
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.
Select...
I am able to care for myself but cannot do normal activities or work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 more

Side effects data

From 2022 Phase 3 trial • 665 Patients • NCT00567567
84%
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%
65900-Pleural effusion
3%
57600-Nausea
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%
26600-Duodenal obstruction
1%
23000-Confusion
1%
71500-Respiratory failure
1%
69700-Rash maculo-papular
1%
42600-Hypoalbuminemia
1%
66300-Pneumonitis
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
~1800
Filgrastim
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,797,952 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,750 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,301 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,363 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

Melphalan Hydrochloride (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03417284 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Group 1 (melphalan hydrochloride, HSCT, filgrastim), Group 2 (melphalan hydrochloride, HSCT, filgrastim)
Multiple Myeloma Clinical Trial 2023: Melphalan Hydrochloride Highlights & Side Effects. Trial Name: NCT03417284 — Phase 1 & 2
Melphalan Hydrochloride (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03417284 — Phase 1 & 2
~6 spots leftby Dec 2024
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