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Monoclonal Antibodies

PF-06863135 Combination Therapy for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and tolerated by patients with multiple myeloma who have relapsed or who are refractory to other treatments.

Who is the study for?
This trial is for adults with multiple myeloma that has come back or didn't respond to standard treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. Participants should be fairly active (able to care for themselves), have good organ function, and not be pregnant. They can't join if they've had recent bleeding issues, severe immune reactions before, other cancers, major surgery or radiation therapy too close to the study start date.Check my eligibility
What is being tested?
The trial tests different ways of giving PF-06863135 alone or with other drugs like pomalidomide, dexamethasone or lenalidomide in patients whose multiple myeloma has relapsed or is refractory. The goal is to find the highest dose patients can take without serious side effects and decide on a recommended dose for future studies.See study design
What are the potential side effects?
Possible side effects include typical drug reactions such as nausea and fatigue but also more serious ones like bone marrow suppression which affects blood cell counts. There may also be risks from combining PF-06863135 with other medications used in the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 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
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)
To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion
To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion
Secondary outcome measures
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
Impact of treatment on systemic soluble immune factors
Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: PF-06863135 + pomalidomideExperimental Treatment1 Intervention
BCMA-CD3 bispecific antibody + pomalidomide
Group II: PF-06863135 + lenalidomideExperimental Treatment1 Intervention
BCMA-CD3 bispecific antibody + lenalidomide
Group III: PF-06863135 + dexamethasoneExperimental Treatment1 Intervention
BCMA-CD3 bispecific antibody + dexamethasone
Group IV: PF-06863135Experimental Treatment1 Intervention
BCMA-CD3 bispecific antibody
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06863135 + dexamethasone
2017
Completed Phase 1
~110
PF-06863135 + pomalidomide
2017
Completed Phase 1
~110
PF-06863135 + lenalidomide
2017
Completed Phase 1
~110
PF-06863135 monotherapy IV or SC
2017
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,772 Total Patients Enrolled
35 Trials studying Multiple Myeloma
9,282 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,940 Total Patients Enrolled
25 Trials studying Multiple Myeloma
4,592 Patients Enrolled for Multiple Myeloma

Media Library

PF-06863135 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03269136 — Phase 1
Multiple Myeloma Research Study Groups: PF-06863135 + pomalidomide, PF-06863135, PF-06863135 + dexamethasone, PF-06863135 + lenalidomide
Multiple Myeloma Clinical Trial 2023: PF-06863135 Highlights & Side Effects. Trial Name: NCT03269136 — Phase 1
PF-06863135 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03269136 — Phase 1

Frequently Asked Questions

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

Could you provide a list of experiments that have evaluated the effects of PF-06863135 combined with lenalidomide?

"First initiated in 2002, the combination of PF-06863135 and lenalidomide has been tested thirteen hundred sixty five times. As of now, there are seven hundred fifteen active trials with a concentration occurring at Atlanta's medical facilities."

Answered by AI

What goals are researchers aiming to accomplish with this investigation?

"Pfizer, the sponsor of this clinical study, has established a primary objective to evaluate anti-myeloma activity over an approximately two year period. The secondary objectives include measuring treatment emergent adverse events and laboratory abnormalities, area under the concentration versus time curve from zero to the last quantifiable point prior to the next dose (AUClast) of PF-06863135 and maximum plasma concentration (Cmax)."

Answered by AI

What locations offer access to this clinical experiment?

"The research team is recruiting for this trial in 38 cities, including Atlanta, Tinley Park and Chicago. To reduce the burden of traveling, it's best to select a location near you as a participant."

Answered by AI

What potential risks are associated with the combination of PF-06863135 and lenalidomide?

"The safety of the combination treatment, PF-06863135 + lenalidomide, has been rated a score of 1 due to its Phase 1 status. This indicates that only scant data exists in regards to this drug's efficacy and safety profile."

Answered by AI

To what types of medical conditions is the combination of PF-06863135 and lenalidomide typically applied?

"PF-06863135 in combination with lenalidomide can be used to treat ophthalmic and sympathetic conditions such as macular edema, branch retinal vein occlusion, and a history of at least two prior systemic chemotherapy regimens."

Answered by AI

Is recruitment of participants presently underway for this experiment?

"Contrary to what one might expect, this clinical trial is not presently enrolling. It was first posted on 11/29/2017 and most recently updated on 7/7/2022. Although it's no longer looking for patients, there are a total of 1522 other medical trials that have available positions at the moment."

Answered by AI

How large is the participant pool of this experiment?

"As of this moment, applications for this medical trial are not being accepted. The study was first posted on November 29th 2017 and has since been amended as recently as July 7th 2022. If you would like to look into other trials, there are presently 807 clinical studies recruiting patients with multiple myeloma and an additional 715 research opportunities involving PF-06863135 in combination with lenalidomide that require participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
2017. "PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03269136.
~14 spots leftby Apr 2025
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