Adult Lymphocyte Depletion Hodgkin LymphomaPhase 1/2NCT00112723

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma

A Phase 1/2 study testing alvocidib in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Lymphocyte Predominant Hodgkin Lymphoma, run by National Cancer Institute (NCI) 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

This phase I/II trial is studying the side effects and best dose of flavopiridol and to see how well it works in treating patients with lymphoma or multiple myeloma. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma
What is being tested?: alvocidib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: Dec 2005to Nov 2015
Phase: Phase 1/2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of 1 of the following hematologic malignancies:
Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL)
Multiple myeloma
Patients in the phase II portion of the study are enrolled in 1 of the following strata according to diagnosis*
Stratum 1: Indolent B-cell NHL (non-Hodgkin's lymphoma), follicle center B-cell NHL (grade 1, 2, or 3), marginal zone lymphoma, Waldenstrom's macroglobulinemia, or small lymphocytic lymphoma (without blood lymphocytosis at any point in the disease process)

Show all 78Show fewer

Must have progressive lymphadenopathy, worsening cytopenias, or progressive symptoms attributed to lymphoma
Must require therapy, as determined by progressive anemia, thrombocytopenia, symptoms (e.g., fever, night sweats, weight loss, or fatigue), or progressive lymphadenopathy that causes discomfort
Received ≥ 2 prior therapies, including rituximab
Stratum 1a: Hairy cell leukemia
Must require therapy, as determined by progressive cytopenias or symptoms (fever, night sweats, weight loss, or fatigue)
Must have received ≥ 2 therapies
Stratum 2: Mantle cell lymphoma, as determined by the presence of cyclin D1 staining OR t(11;14)
Stratum 3: Intermediate grade B-cell NHL, including diffuse large B-cell NHL and T-cell rich B-cell NHL
Diffuse large B-cell NHL arising from an indolent NHL (i.e., transformed lymphoma) allowed
Ineligible for potentially curative autologous stem cell transplantation
Stratum 4: T-cell and natural killer-cell NHL, including anaplastic large cell lymphoma and peripheral T-cell NHL
Primary cutaneous lymphoma or Sezary syndrome allowed provided criteria for measurable disease are met
Received ≥ 1 prior systemic therapy
Stratum 5: Hodgkin's lymphoma
Any of the following subtypes are allowed:
Nodular sclerosing
Mixed cellularity
Lymphocyte predominant
Lymphocyte depleted
Ineligible for potentially curative autologous stem cell transplantation
Stratum 6: Progressive stage I or stage II or IIIA multiple myeloma meeting ≥ 1 major and 1 minor criterion OR ≥ 3 minor criteria as follows:
Major criteria
Plasmacytoma on tissue biopsy
Bone marrow plasmacytosis ≥ 30% of marrow cellularity
Monoclonal paraprotein ≥ 3,500 mg/dL (IgG), or ≥ 2,000 mg/dL (IgA), OR monoclonal protein (Bence-Jones protein) ≥ 1,000 mg by 24-hour urine collection
Minor criteria
Bone marrow plasmacytosis 10-29% of marrow cellularity
Monoclonal paraprotein < 3,500 mg/dL (IgG) or < 2,000 mg/dL (IgA)
Lytic bone lesions by x-ray or CT scan
Decrease in normal IgM (< 50 mg/dL), IgA (< 100 mg/dL), or IgG (< 600 mg/dL)
Relapsed or refractory disease
Measurable disease, defined by 1 of the following:
At least 1 node > 2 cm by CT scan
Measurable disease in a lymphoid structure (i.e., spleen) by CT scan
Bone marrow involvement (> 20% of marrow cellularity)
Patients with multiple myeloma must have detectable serum or urinary paraprotein
Patients with only cutaneous or subcutaneous disease (i.e., no measurable lymph node or bone marrow disease) are eligible if the extent of rash or skin involvement OR the size of the nodules are measurable
Must have received ≥ 1 prior therapy
Steroids alone are not considered prior therapy for patients with NHL or Hodgkin's lymphoma
High-dose dexamethasone is considered 1 prior therapy for patients with multiple myeloma
No standard effective therapy exists
No HIV-associated lymphoma
No nonsecretory multiple myeloma
Performance status - ECOG (Eastern Cooperative Oncology Group) 0-2
No concurrent hormonal therapy except steroids for new adrenal failure or hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
Hemoglobin ≥ 9.0 g/dL*
Absolute neutrophil count ≥ 1,500/mm^3*
Platelet count ≥ 50,000/mm^3*
AST (aspartate aminotransferase) ≤ 3 times upper limit of normal (ULN)
Bilirubin ≤ 2 times ULN
No major renal dysfunction that would preclude study compliance or participation
Phase I:
Creatinine ≤ 1.5 mg/dL
Creatinine clearance ≥ 70 mL/min
Phase II:
Creatinine ≤ 2.0 mg/dL
Creatinine clearance ≥ 50 mL/min
No cardiac or vascular dysfunction that would preclude central venous access, vigorous hydration, or hemodialysis
No other major cardiac dysfunction that would preclude study compliance or participation
No major pulmonary dysfunction that would preclude study compliance or participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No chronic gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) that would preclude study compliance or participation
No other major organ system (including neurological or psychiatric) dysfunction that would preclude study compliance or participation
Prior radiotherapy, including radioimmunotherapy, allowed
No concurrent radiotherapy
Prior idiotype vaccination or stem cell transplantation allowed
More than 6 weeks since prior mitomycin or nitrosoureas
No other concurrent chemotherapy
More than 4 weeks since other prior therapy
Prior systemic steroids allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I/II Study of Flavopiridol Administered as a 30-Minute Bolus Followed by a 4-Hour Infusion in Lymphomas and Multiple Myeloma

Read the detailed description

PRIMARY OBJECTIVES:

Determine the disease-specific dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with relapsed or refractory lymphoma or multiple myeloma.

II. Determine the complete and partial response rate in patients with selected non-Hodgkin's lymphoma (e.g., indolent B-cell, mantle cell, intermediate grade B-cell, and T/NK-cell), Hodgkin's lymphoma, or multiple myeloma treated with this drug.

III. Determine the qualitative and quantitative toxic effects or this drug, in terms of organ specificity, time course, predictability, and reversibility in these patients.

IV. Determine subsets of lymphoid/plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

Determine the pharmacokinetics of this drug in these patients. II. Determine the effect of this drug on innate immunity (including T-, B-, and NK-cell subsets) and quantitative immunoglobulin levels in these patients.

III. Determine whether acute infusion toxicity (e.g., fever, hypotension, tumor pain, and dyspnea) observed with other flavopiridol treatment schedules is related to a cytokine-release syndrome in these patients.

IV. Determine whether this drug induces response (independent of p53 mutational status) in these patients.

OUTLINE: This is a phase I, dose-escalation study followed by a multicenter, phase II, pilot study. Patients enrolled in the phase II portion of the study are stratified according to diagnosis.

PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.

NOTE: The phase II treatment dose and schedule for hairy cell leukemia patients will be adapted from that developed in previous phase II studies of flavopiridol for the treatment of chronic lymphocytic leukemia.

After completion of study therapy, patients are followed every 3 months for 2 years.

Conditions: Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
Being tested: alvocidib
Medical subject headings: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Cutaneous

What participants receive

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

alvocidibDrug
Also called FLAVO, flavopiridol, HMR 1275, L-868275
Given IV

Study groups in NCT00112723
Study group	Role	What they receive
Treatment (alvocidib)	Experimental	PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I. Receives: Drug: alvocidib

What is being measured

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

Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)
Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
Measured: 28 days
Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
Measured: 28 days
Complete and Partial Response Rate (Phase II)
Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
Measured: Up to 2 years
Qualitative and Quantitative Toxicities in Regard to Organ Specificity
The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.
Measured: Up to 30 days after completion of study treatment
Lymphoid/Plasma Cell Malignancies
Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.
Measured: Up to 2 years

Secondary outcomes (5)

Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol
Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1
Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)
Measured: Up to 30 days after completion of study treatment
Induced Response in Patients Independent of p53 Mutational Status
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 2 years
Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).
The correlation of the pharmacodynamic effects of flavopiridol on normal peripheral blood mononuclear cells (PBMCs)
Measured: Day 1
Pharmacokinetics (Cmax) of Flavopiridol
Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1

Timeline

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

Dec 2005Nov 2015

First posted3 Jun 2005 (estimated)
Study startDec 2005
Primary completionFeb 2011
Study completionNov 2015

Why it stopped: Administratively Complete

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adult Lymphocyte Depletion Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00112723
Sponsor's protocol ID: NCI-2011-01346
Other IDs: NCI-2011-01346, OSU-04100, CDR0000429577, OSU-2005C0006, NCI-7002, OSU 04100, 7002, U01CA076576
Status last verified: Jun 2016
First submitted: 2 Jun 2005
Last updated: 8 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Hofmeister CC, Poi M, Bowers MA, Zhao W, Phelps MA, Benson DM, Kraut EH, Farag S, Efebera YA, Sexton J, Lin TS, Grever M, Byrd JC. A phase I trial of flavopiridol in relapsed multiple myeloma. Cancer Chemother Pharmacol. 2014 Feb;73(2):249-57. doi: 10.1007/s00280-013-2347-y. Epub 2013 Nov 16.
PubMed 24241210

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Flavopiridol Administered as a 30-Minute Bolus Followed by a 4-Hour Infusion in Lymphomas and Multiple Myeloma
ClinicalTrials.gov ID: NCT00112723
Acronym / sponsor ID: NCI-2011-01346
Conditions: Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Administratively Complete
Enrolment: 46 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Dec 2005
Primary completion: Feb 2011 (actual)
Study completion: Nov 2015 (actual)
First posted: 3 Jun 2005 (estimated)
Results: Posted 8 Aug 2016

Clinical summary

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

Detailed description

PRIMARY OBJECTIVES:

Determine the disease-specific dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with relapsed or refractory lymphoma or multiple myeloma.

III. Determine the qualitative and quantitative toxic effects or this drug, in terms of organ specificity, time course, predictability, and reversibility in these patients.

IV. Determine subsets of lymphoid/plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

Determine the pharmacokinetics of this drug in these patients. II. Determine the effect of this drug on innate immunity (including T-, B-, and NK-cell subsets) and quantitative immunoglobulin levels in these patients.

IV. Determine whether this drug induces response (independent of p53 mutational status) in these patients.

OUTLINE: This is a phase I, dose-escalation study followed by a multicenter, phase II, pilot study. Patients enrolled in the phase II portion of the study are stratified according to diagnosis.

PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.

After completion of study therapy, patients are followed every 3 months for 2 years.

Study design

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

Arm	Type	Receives
Treatment (alvocidib)	Experimental	Drug: alvocidibPHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.

Who may qualify

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

Key inclusion criteria (78 listed)

Diagnosis of 1 of the following hematologic malignancies:
Patients in the phase II portion of the study are enrolled in 1 of the following strata according to diagnosis*
Relapsed or refractory disease
Measurable disease, defined by 1 of the following:
Must have received ≥ 1 prior therapy

Key exclusion criteria (0 listed)

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
alvocidibAlso: FLAVO, flavopiridol, HMR 1275, L-868275Given IV	Drug	Treatment (alvocidib)

Primary outcome

Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)
Time frame: 28 days
Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.
Maximum Tolerated Dose (MTD)
Time frame: 28 days
The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
Complete and Partial Response Rate (Phase II)
Time frame: Up to 2 years
Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
Qualitative and Quantitative Toxicities in Regard to Organ Specificity
Time frame: Up to 30 days after completion of study treatment
The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.
Lymphoid/Plasma Cell Malignancies
Time frame: Up to 2 years
Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.

5 secondary outcomes

Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1
Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)
Time frame: Up to 30 days after completion of study treatment
Induced Response in Patients Independent of p53 Mutational Status
Time frame: Up to 2 years
Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).
Time frame: Day 1
Pharmacokinetics (Cmax) of Flavopiridol
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1

Results and safety

Results posted to the registry on 8 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)	13	11
Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)	19	12
Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)	14	12

Primary outcome: Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)

Time frame: 28 days. Number. Unit: patients

Measure	Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) n = 11	Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) n = 19	Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) n = 14
Value	0	0	0

Primary outcome: Maximum Tolerated Dose (MTD)

Time frame: 28 days. Number. Unit: mg/m2

Measure	Dose Level 1 (30+30) n = 11	Level 2 (30+50) n = 12	Level 3 (50+50) n = 12
Value	60	80	100

Primary outcome: Complete and Partial Response Rate (Phase II)

Time frame: Up to 2 years. Number. Unit: patients

Measure	Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) n = 12	Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) n = 17	Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2) n = 14
Complete Response	0	0	0
Partial Response	2	2	2

Population analysed: Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL

Primary outcome: Qualitative and Quantitative Toxicities in Regard to Organ Specificity

Time frame: Up to 30 days after completion of study treatment. Number. Unit: percentage of patients

Measure	Dose Levels 1, 2, 3 n = 35
Leukopenia	86
Neutropenia	23
Infection	20
Diarrhea	51
Fatigue	34

Population analysed: Grade 3 and 4 toxicities.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were assessed for clinical response after two, four and six cycles with laboratory studies, physical exam, and CT scans.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Alvocidib)	0 of 35 (0%)	34 of 35 (97.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24241210Hofmeister CC, Poi M, Bowers MA, Zhao W, Phelps MA, Benson DM, Kraut EH, Farag S, Efebera YA, Sexton J, Lin TS, Grever M, Byrd JC. A phase I trial of flavopiridol in relapsed multiple myeloma. Cancer Chemother Pharmacol. 2014 Feb;73(2):249-57. doi: 10.1007/s00280-013-2347-y. Epub 2013 Nov 16.

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.

Jeffrey Jones principal investigator

Ohio State University

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?

The sponsor lists 78 inclusion and 0 exclusion criteria. 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 8 Aug 2016. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Aug 2016). 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?

Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I) (time frame: 28 days). The study lists 5 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 NCT00112723, which also lists 1 linked publication.

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 8 Aug 2016.