Multiple MyelomaPhase 1/2NCT00903968

Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Plerixafor, bortezomib and Dexamethasone in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Plerixafor, bortezomib and Dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 5 sitesUnited States
Study dates: 1 Jun 2009to Oct 2016
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

18 years of age or older
Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
ECOG Performance Status 0, 1, or 2
Laboratory values as outlined in the protocol

Who cannot join

Uncontrolled infection
Cytotoxic chemotherapy < 3 weeks, or biologic or targeted novel therapy < 2 weeks, or corticosteroids < 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
Pregnant women
Nursing women
Men or women of child-bearing potential who are unwilling to employ adequate contraception
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
Known to be HIV positive
Radiation therapy < 2 weeks prior to registration

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Milford Hospital
Milford, Massachusetts, 01757
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Cancer Treatment Centers of America (Eastern Regional Medical Center)
Philadelphia, Pennsylvania, 19124

Other trials in United States

About this study

Official title: Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.

Conditions: Multiple Myeloma
Being tested: Plerixafor, bortezomib, Dexamethasone
Keywords: refractory, relapsed, bortezomib, AMD3100, plerixafor
Medical subject headings: Multiple Myeloma, Recurrence

What participants receive

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

PlerixaforDrug
Also called AMD3100
bortezomibDrug
Also called velcade
DexamethasoneDrug
Also called Decadron

Study groups in NCT00903968
Study group	Role	What they receive
Phase I Dose Level 1	Experimental	Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
Phase I Dose Level 2	Experimental	Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
Phase I Dose Level 3	Experimental	Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
Phase I Dose Level 4	Experimental	Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
Phase I Dose Level 5	Experimental	Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
Phase I Dose Level 5B	Experimental	Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
Phase I Dose Level 6	Experimental	Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
All Phase I Participants	Experimental	All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib
All Phase II Participants	Experimental	All Phase I participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity. Receives: Drug: Plerixafor; Drug: bortezomib; Drug: Dexamethasone

What is being measured

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

Plerixafor Maximum Tolerated Dose (MTD) [Phase I]
The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.
Measured: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
Bortezomib Maximum Tolerated Dose (MTD) [Phase I]
The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of bortezomib was given on days 3, 6, 10, 13 of 21 each cycle.
Measured: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]
A DLT was defined as (a) grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to plerixafor or bortezomib, with the exception of nausea, vomiting or diarrhea unless receiving maximal medical therapy, (b) grade 4 hematologic toxicity defined as: thrombocytopenia with platelets <10,000 on more than one occasion within first cycle despite transfusion. Grade 4 neutropenia must occur for more than 5 days and/or result in neutropenic fever with elevated temperature (defined as > 101 degrees F). (c) inability to receive Day 1 dose for Cycle 2 due to toxicity. All adverse events were graded according to the CTEP Common Toxicity Criteria (CTCAE v.3.0).
Measured: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]
Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component <100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component <200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).
Measured: Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.

Secondary outcomes (2)

Time to Progression (TTP) [Phase II]
TTP estimated using the Kaplan-Meier method is defined as the time from registration to progression based on IMWG criteria or date last known progression-free for those who have not progressed. [Durie BG et al. Leukemia. 2006] Progression (PD): ≥ 25% increase from lowest value reported in serum M-component (absolute increase ≥0.5 g/dL) and/or urine M-component (absolute increase ≥200 mg/24 hours); if appropriate, a ≥25% increase above the lowest level in the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); If none of these are measurable then ≥25% increase in bone marrow plasma cell percentage above the lowest response level (absolute ≥10%); Definite development of new bone lesions or soft tissue plasmacytomas OR increase in size of existing
Measured: DIsease was assessed to document progression every cycle on treatment and post-treatment every 12 weeks until progression.
Duration of Response (DOR) [Phase II]
DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.
Measured: DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.

Timeline

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

1 Jun 2009Oct 2016

First posted19 May 2009 (estimated)
Study start1 Jun 2009
Primary completionJun 2016
Study completionOct 2016

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 Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00903968
Sponsor's protocol ID: 08-273
Status last verified: May 2020
First submitted: 18 May 2009
Last updated: 2 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ghobrial IM, Liu CJ, Zavidij O, Azab AK, Baz R, Laubach JP, Mishima Y, Armand P, Munshi NC, Basile F, Constantine M, Vredenburgh J, Boruchov A, Crilley P, Henrick PM, Hornburg KTV, Leblebjian H, Chuma S, Reyes K, Noonan K, Warren D, Schlossman R, Paba-Prada C, Anderson KC, Weller E, Trippa L, Shain K, Richardson PG. Phase I/II trial of the CXCR4 inhibitor plerixafor in combination with bortezomib as a chemosensitization strategy in relapsed/refractory multiple myeloma. Am J Hematol. 2019 Nov;94(11):1244-1253. doi: 10.1002/ajh.25627. Epub 2019 Oct 4.
PubMed 31456261

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

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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT00903968
Acronym / sponsor ID: 08-273
Conditions: Multiple Myeloma
Keywords: refractory, relapsed, bortezomib, AMD3100, plerixafor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: Brigham and Women's Hospital, Genzyme, a Sanofi Company, Millennium Pharmaceuticals, Inc.
Study start: 1 Jun 2009 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 19 May 2009 (estimated)
Results: Posted 29 Sep 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Phase I Dose Level 1	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 2	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 3	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 4	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 5	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 5B	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 6	Experimental	Drug: Plerixafor, Drug: bortezomibPhase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
All Phase I Participants	Experimental	Drug: Plerixafor, Drug: bortezomibAll Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
All Phase II Participants	Experimental	Drug: Plerixafor, Drug: bortezomib, Drug: DexamethasoneAll Phase I participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.

Who may qualify

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

Key inclusion criteria (5 listed)

18 years of age or older
Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
ECOG Performance Status 0, 1, or 2
Laboratory values as outlined in the protocol

Key exclusion criteria (8 listed)

Uncontrolled infection
Cytotoxic chemotherapy < 3 weeks, or biologic or targeted novel therapy < 2 weeks, or corticosteroids < 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
Pregnant women
Nursing women
Men or women of child-bearing potential who are unwilling to employ adequate contraception

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
PlerixaforAlso: AMD3100	Drug	All Phase I Participants, All Phase II Participants, Phase I Dose Level 1, Phase I Dose Level 2, Phase I Dose Level 3, Phase I Dose Level 4, Phase I Dose Level 5, Phase I Dose Level 5B, Phase I Dose Level 6
bortezomibAlso: velcade	Drug	All Phase I Participants, All Phase II Participants, Phase I Dose Level 1, Phase I Dose Level 2, Phase I Dose Level 3, Phase I Dose Level 4, Phase I Dose Level 5, Phase I Dose Level 5B, Phase I Dose Level 6
DexamethasoneAlso: Decadron	Drug	All Phase II Participants

Primary outcome

Plerixafor Maximum Tolerated Dose (MTD) [Phase I]
Time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.
Bortezomib Maximum Tolerated Dose (MTD) [Phase I]
Time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of bortezomib was given on days 3, 6, 10, 13 of 21 each cycle.
Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]
Time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
A DLT was defined as (a) grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to plerixafor or bortezomib, with the exception of nausea, vomiting or diarrhea unless receiving maximal medical therapy, (b) grade 4 hematologic toxicity defined as: thrombocytopenia with platelets <10,000 on more than one occasion within first cycle despite transfusion. Grade 4 neutropenia must occur for more than 5 days and/or result in neutropenic fever with elevated temperature (defined as > 101 degrees F). (c) inability to receive Day 1 dose for Cycle 2 due to toxicity. All adverse events were graded according to the CTEP Common Toxicity Criteria (CTCAE v.3.0).
Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]
Time frame: Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.
Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component <100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component <200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).

2 secondary outcomes

Time to Progression (TTP) [Phase II]
Time frame: DIsease was assessed to document progression every cycle on treatment and post-treatment every 12 weeks until progression.
Duration of Response (DOR) [Phase II]
Time frame: DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.

Results and safety

Results posted to the registry on 29 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I Dose Level 1	3	0
Phase I Dose Level 2	3	0
Phase I Dose Level 3	3	0
Phase I Dose Level 4	3	0
Phase I Dose Level 5	4	0
Phase I Dose Level 5B	6	0
Phase I Dose Level 6	3	0
All Phase II Participants	33	0

Primary outcome: Plerixafor Maximum Tolerated Dose (MTD) [Phase I]

Time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.. Number. Unit: ug/kg

Measure	All Phase I Particiapnts n = 25
Value	320

Population analysed: All Phase I participants who received at least one dose of the study drug were evaluable for MTD.

Primary outcome: Bortezomib Maximum Tolerated Dose (MTD) [Phase I]

Time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.. Number. Unit: mg/m2

Measure	All Phase I Particiapnts n = 25
Value	1.3

Population analysed: All Phase I participants who received at least one dose of the study drug were evaluable for MTD.

Primary outcome: Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]

Time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.. Count of participants. Unit: Participants

Measure	Phase I Dose Level 1 n = 3	Phase I Dose Level 2 n = 3	Phase I Dose Level 3 n = 3	Phase I Dose Level 4 n = 3	Phase I Dose Level 5 n = 4	Phase I Dose Level 5B n = 6	Phase I Dose Level 6 n = 3
Value	0	0	0	0	0	0	2

Population analysed: All Phase I participants who received at least one dose of the study drug were evaluable for DLT.

Primary outcome: Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]

Time frame: Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.. Count of participants. Unit: Participants

Measure	Phase I Dose Level 1 n = 3	Phase I Dose Level 2 n = 3	Phase I Dose Level 3 n = 3	Phase I Dose Level 4 n = 3	Phase I Dose Level 5 n = 4	Phase I Dose Level 5B n = 6	Phase I Dose Level 6 n = 3	All Phase II Participants n = 33
Complete Response	0	0	1	0	0	0	0	1
Very Good Partial Response	0	0	0	0	0	0	1	3
Partial Response	0	0	0	0	0	1	0	12
Minimal Response	0	0	0	2	0	1	0	4
Stable Disease	3	2	2	0	4	3	2	11
Progressive Disease	0	1	0	1	0	1	0	2

Population analysed: All participants with measureable disease at baseline and received at least one dose of the study drug were evaluable for response.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Assessed each treatment cycle from time of first dose and up to day 30 post treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I Dose Level 1	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Phase I Dose Level 2	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Phase I Dose Level 3	0 of 3 (0%)	3 of 3 (100%)	Not reported
Phase I Dose Level 4	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Phase I Dose Level 5	2 of 4 (50%)	4 of 4 (100%)	Not reported
Phase I Dose Level 5B	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
Phase I Dose Level 6	0 of 3 (0%)	3 of 3 (100%)	Not reported
All Phase I Participants	8 of 25 (32%)	25 of 25 (100%)	Not reported
All Phase II Participants	14 of 33 (42.4%)	33 of 33 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31456261Ghobrial IM, Liu CJ, Zavidij O, Azab AK, Baz R, Laubach JP, Mishima Y, Armand P, Munshi NC, Basile F, Constantine M, Vredenburgh J, Boruchov A, Crilley P, Henrick PM, Hornburg KTV, Leblebjian H, Chuma S, Reyes K, Noonan K, Warren D, Schlossman R, Paba-Prada C, Anderson KC, Weller E, Trippa L, Shain K, Richardson PG. Phase I/II trial of the CXCR4 inhibitor plerixafor in combination with bortezomib as a chemosensitization strategy in relapsed/refractory multiple myeloma. Am J Hematol. 2019 Nov;94(11):1244-1253. doi: 10.1002/ajh.25627. Epub 2019 Oct 4.

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Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1/2
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
Multiple Myeloma
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A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin

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.

Irene Ghobrial, MD principal investigator

Dana-Farber Cancer Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Plerixafor, bortezomib and Dexamethasone in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 5 sites in United States.

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 29 Sep 2017). 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?

Plerixafor Maximum Tolerated Dose (MTD) [Phase I] (time frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.). 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 NCT00903968, 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 2 Jun 2020.