Multiple Myeloma and Plasma Cell NeoplasmEarly Phase 1NCT00470093

Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma

A Early Phase 1 study testing recombinant interferon-α and recombinant interleukin-6 in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells. Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Multiple Myeloma and Plasma Cell Neoplasm
What is being tested?: recombinant interferon-α and recombinant interleukin-6
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Jan 2010
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

DISEASE CHARACTERISTICS:

Diagnosis of recurrent multiple myeloma
Must have received ≥ 2 prior therapies

PATIENT CHARACTERISTICS:

Performance status 0-3

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.

Read the detailed description

OBJECTIVES:

Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
Determine the safety and optimal dose of this regimen in these patients.
Determine the toxicity of this regimen in these patients.
Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.

OUTLINE: This is a pilot study.

Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Being tested: recombinant interferon-α, recombinant interleukin-6
Keywords: refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings: Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

recombinant interferon-αBiological
recombinant interleukin-6Biological

Study groups in NCT00470093
Study group	Role	What they receive
Interleukin-6 and Interferon-α	Experimental	Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day. Receives: Biological: recombinant interferon-α; Biological: recombinant interleukin-6

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
Number of participants with partial or complete response by Bladé criteria where partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.
Measured: Up to 5 months
Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
Number of participants who discontinued the protocol due to adverse events.
Measured: Up to 5 months
Optimal Dose of Interleukin-6
Maximum tolerated dose found using a standard 3+3 dose escalation model.
Measured: Up to 5 months
Impact of Treatment on Growth of Myeloma Cells
Percentage change in growth of in vitro myeloma cells from baseline to end of study.
Measured: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jan 2010

First posted7 May 2007 (estimated)
Study startOct 2007
Primary completionJan 2010
Study completionJan 2010

Why it stopped: Low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00470093
Sponsor's protocol ID: J0620
Other IDs: P30CA006973, P01CA015396, NA_00002178
Status last verified: Oct 2018
First submitted: 3 May 2007
Last updated: 16 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma and Plasma Cell Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a
ClinicalTrials.gov ID: NCT00470093
Acronym / sponsor ID: J0620
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low accrual
Enrolment: 3 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Oct 2007 (actual)
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 7 May 2007 (estimated)
Results: Posted 16 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.

Detailed description

OBJECTIVES:

Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
Determine the safety and optimal dose of this regimen in these patients.
Determine the toxicity of this regimen in these patients.
Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.

OUTLINE: This is a pilot study.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Interleukin-6 and Interferon-α	Experimental	Biological: recombinant interferon-α, Biological: recombinant interleukin-6Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
recombinant interferon-α	Biological	Interleukin-6 and Interferon-α
recombinant interleukin-6	Biological	Interleukin-6 and Interferon-α

Primary outcome

Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
Time frame: Up to 5 months
Number of participants with partial or complete response by Bladé criteria where partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.
Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
Time frame: Up to 5 months
Number of participants who discontinued the protocol due to adverse events.
Optimal Dose of Interleukin-6
Time frame: Up to 5 months
Maximum tolerated dose found using a standard 3+3 dose escalation model.
Impact of Treatment on Growth of Myeloma Cells
Time frame: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study
Percentage change in growth of in vitro myeloma cells from baseline to end of study.

Results and safety

Results posted to the registry on 16 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interleukin-6 and Interferon-α	2	0

Primary outcome: Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.

Time frame: Up to 5 months. Count of participants. Unit: Participants

Measure	Interleukin-6 and Interferon-α n = 2
Value	0

Primary outcome: Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events

Time frame: Up to 5 months. Count of participants. Unit: Participants

Measure	Interleukin-6 and Interferon-α n = 2
Value	2

Primary outcome: Optimal Dose of Interleukin-6

Time frame: Up to 5 months

Population analysed: This outcome cannot be evaluated as zero participants tolerated the study regimen. All participants were enrolled on the 2.5 mg arm and a maximum tolerated dose was not found.

Primary outcome: Impact of Treatment on Growth of Myeloma Cells

Time frame: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study

Population analysed: Zero participants tolerated protocol therapy and the research sample blood draws were therefore not completed as planned. Because of this, the data from this outcome could not be collected.

Adverse events

Time frame: Up to 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interleukin-6 and Interferon-α	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma and Plasma Cell Neoplasm

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carol A Huff, MD study chair

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria. (time frame: Up to 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00470093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.