← Back to Search

Alkylating Agent

Chemotherapy + Stem Cell Transplant for Multiple Myeloma

Q: Am I qualified to join the research project?

This trial is open for enrolment of 83 adults, aged 18 to 65 years old, who have been diagnosed with one of the following: <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> plasma cell, less than partial response (PR) to first-line therapy or relapse after a prior autologous stem cell <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> (ASCT). Additionally, applicants must meet several health criteria including but not limited to: creatinine levels lower than 1.8 mg/dL and estimated serum creatinine clearance higher than 50 ml/min; SGOT and/or SGPT values below 3x upper limit of normal; bilirubin values lower than 2x ULN unless proved

Q: Is it still possible to volunteer for this clinical investigation?

As indicated on clinicaltrials.gov, this project is not currently recruiting participants. The trial was initiated in September 2015 and last updated in October 2022; however, there are 1,390 other studies that continue to actively recruit patients at present.

Q: What medical conditions is Panobinostat typically employed to address?

Panobinostat has been shown to be an effective treatment for urinary bladder and several other cancers, including <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/sclc">SCLC</a>), head and neck carcinoma, as well as cervical malignancies.

Q: To what degree is Panobinostat a hazard to patients?

Our team at Power have assigned Panobinostat a safety rating of 2, as this is an early-stage clinical trial with some evidence to support its security but none regarding the effectiveness.

Q: Does this trial permit elderly individuals to participate?

This medical trial will include participants aged 18 or over and below the age of 65.

Q: Could you please expound upon the previous research that has been conducted concerning Panobinostat?

Presently, there are 578 clinical trials for Panobinostat in progress; 150 of which are Phase 3 studies. The majority of the experiments take place in Woolloongabba, Queensland yet 26706 sites across the world offer this medication to patients.

Q: What is the aggregate figure of individuals participating in this research endeavor?

At this time, no further participants are being sought for the clinical trial initially posted on September 14th 2015 and edited most recently on October 6th 2022. However, if you're seeking out alternative studies, 812 trials recruiting patients with <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> or plasma cell diseases and 578 trials utilising panobinostat are currently enrolling individuals.

Phase 2

Waitlist Available

Led By Yago L Nieto

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

Zubrod performance status < 2

Clinically euthyroid

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying panobinostat in combination with gemcitabine hydrochloride, busulfan, and melphalan before stem cell transplant to see how well it works in treating patients with multiple myeloma that does not respond to treatment or has returned.

Who is the study for?

This trial is for patients with multiple myeloma that hasn't improved or has come back after treatment. They must have good kidney, liver, lung, and heart function; a performance status indicating they can carry out daily activities; not be pregnant; and have enough previously collected stem cells for transplant. People with active infections, HIV, recent major surgery or malignancy, severe medical conditions, GI impairments or hepatitis B/C cannot participate.Check my eligibility

What is being tested?

The study tests if panobinostat combined with high-dose chemotherapy (gemcitabine hydrochloride, busulfan, melphalan) before a stem cell transplant can effectively treat refractory/relapsed multiple myeloma. The process involves destroying cancer cells and making space in the bone marrow for new blood-forming cells from previously collected stem cells.See study design

What are the potential side effects?

Potential side effects include reactions to enzyme inhibition by panobinostat which may affect cell growth processes. High-dose chemotherapy could lead to significant reduction of blood cells causing anemia and increased infection risk. Organ damage due to intensive drug therapy might also occur.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can carry out all my self-care but cannot work.

Select...

My thyroid function is normal.

Select...

My liver is working well.

Select...

My myeloma has returned or is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Progression free survival (PFS)

Secondary outcome measures

Complete response (CR) + very good partial response (VGPR) rate

Complete response (CR) rate

Incidence of grade 3 or greater side effects

+5 more

Side effects data

From 2012 Phase 3 trial • 41 Patients • NCT01034163

88%

Diarrhoea

58%

Nausea

46%

Vomiting

35%

Fatigue

27%

Neutropenia

27%

Thrombocytopenia

27%

Oropharyngeal pain

23%

Headache

19%

Upper respiratory tract infection

19%

Nasopharyngitis

15%

Sinusitis

15%

Influenza like illness

15%

Pyrexia

15%

Decreased appetite

12%

Leukopenia

12%

Muscle spasms

12%

Depression

12%

Arthralgia

12%

Cough

12%

Dysgeusia

12%

Gastrooesophageal reflux disease

12%

Asthenia

Urinary tract infection

Mucosal dryness

Herpes virus infection

Back pain

Polyneuropathy

Paranasal sinus hypersecretion

Abdominal pain upper

Constipation

Platelet count decreased

Sinusitis bacterial

Cellulitis

Gastroenteritis salmonella

Insomnia

Non-cardiac chest pain

Hypophosphataemia

Pruritus

Abdominal pain

Chills

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Panobinostat (PAN)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (panobinostat, Gem/Bu/Mel, ASCT)Experimental Treatment8 Interventions

Patients receive panobinostat PO QD on days -9 to -2, gemcitabine hydrochloride IV over 4 hours on days -8 and -3, busulfan IV over 3 hours on days -8 to -5, and melphalan IV over 30 minutes on days -3 and -2. Patients then undergo autologous peripheral blood stem cell transplant on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~1730

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Busulfan

2008

Completed Phase 3

~1120

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Panobinostat

2011

Completed Phase 3

~1560

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,719 Total Patients Enrolled

76 Trials studying Multiple Myeloma

5,734 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,584 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,047 Patients Enrolled for Multiple Myeloma

Yago L NietoPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

102 Total Patients Enrolled

Media Library

Busulfan (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02506959 — Phase 2

Multiple Myeloma Research Study Groups: Treatment (panobinostat, Gem/Bu/Mel, ASCT)

Multiple Myeloma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT02506959 — Phase 2

Busulfan (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02506959 — Phase 2

Frequently Asked Questions

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

Am I qualified to join the research project?

"This trial is open for enrolment of 83 adults, aged 18 to 65 years old, who have been diagnosed with one of the following: leukemia plasma cell, less than partial response (PR) to first-line therapy or relapse after a prior autologous stem cell transplant (ASCT). Additionally, applicants must meet several health criteria including but not limited to: creatinine levels lower than 1.8 mg/dL and estimated serum creatinine clearance higher than 50 ml/min; SGOT and/or SGPT values below 3x upper limit of normal; bilirubin values lower than 2x ULN unless proved"

Answered by AI

Is it still possible to volunteer for this clinical investigation?

"As indicated on clinicaltrials.gov, this project is not currently recruiting participants. The trial was initiated in September 2015 and last updated in October 2022; however, there are 1,390 other studies that continue to actively recruit patients at present."

Answered by AI

What medical conditions is Panobinostat typically employed to address?

"Panobinostat has been shown to be an effective treatment for urinary bladder and several other cancers, including small cell lung cancer (SCLC), head and neck carcinoma, as well as cervical malignancies."

Answered by AI

To what degree is Panobinostat a hazard to patients?

"Our team at Power have assigned Panobinostat a safety rating of 2, as this is an early-stage clinical trial with some evidence to support its security but none regarding the effectiveness."

Answered by AI

Does this trial permit elderly individuals to participate?

"This medical trial will include participants aged 18 or over and below the age of 65."

Answered by AI

Could you please expound upon the previous research that has been conducted concerning Panobinostat?

"Presently, there are 578 clinical trials for Panobinostat in progress; 150 of which are Phase 3 studies. The majority of the experiments take place in Woolloongabba, Queensland yet 26706 sites across the world offer this medication to patients."

Answered by AI

What is the aggregate figure of individuals participating in this research endeavor?

"At this time, no further participants are being sought for the clinical trial initially posted on September 14th 2015 and edited most recently on October 6th 2022. However, if you're seeking out alternative studies, 812 trials recruiting patients with leukemia or plasma cell diseases and 578 trials utilising panobinostat are currently enrolling individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma

2015. "Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02506959.

All > Plasma Cell Leukemia > Myeloma